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    Summary
    EudraCT Number:2012-005748-12
    Sponsor's Protocol Code Number:GASTRICHIP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-005748-12
    A.3Full title of the trial
    D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in locally advanced Gastric Carcinoma: international randomized and multicentric Phase III Study
    Resección D2 y HIPEC (quimioperfusión hipertérmica intraperitoneal) en el carcinoma gástrico localmente avanzado: estudio aleatorizado y multicéntrico de fase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III trial evaluating the site of intraperitoneal peroperative chemo-hyperthermia (CHIP) after maximal resection of a gastric-derived peritoneal carcinomatosis associated with systemic chemotherapy
    Ensayo de fase III que evalúa el lugar de la Quimio-Hipertermia Intraperitoneal Peroperatoria (CHIP) luego de la resección máxima de una carcinomatosis peritoneal de origen gástrico asociada a una quimioterapia sistémica
    A.3.2Name or abbreviated title of the trial where available
    GASTRICHIP TRIAL
    Ensayo GASTRICHIP
    A.4.1Sponsor's protocol code numberGASTRICHIP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointValerie Plattner
    B.5.3 Address:
    B.5.3.1Street Address3, quai des Célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post codeF - 69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+00334 72 40 68 40
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Oxaliplatin
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name 5 Fluorouracilo
    D.2.1.1.2Name of the Marketing Authorisation holderAccord
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name5 Fluorouracilo
    D.3.2Product code L01B1A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Levofolinate Calcium
    D.2.1.1.2Name of the Marketing Authorisation holderNormon
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia (Appendix 6)
    I 10 Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
    Adenocarcinoma gástrico y / o adenocarcinoma gástrico perforado y / o adenocarcinoma Siewert III de cardias (Apéndice 6)
    I 10 Prueba histológica de T3 o T4 resecable para la cual se ha programado una gastrectomía curativa, con invasión a la serosa y / o metástasis ganglionar (determinada a partir de datos obtenidos por ecografía endoscópica y tomografía computarizada de tórax, abdomen y pelvis) Y / o citología peritoneal positiva (Muestreadas durante la laparoscopia preoperatoria).
    E.1.1.1Medical condition in easily understood language
    Advanced gastric adenocarcinoma and/or positive lymph nodes and/or positive cytology
    Adenocarcinoma gástrico avanzado y / o ganglios linfáticos positivos y / o citología positiva
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
    Comparar las tasas generales de supervivencia a los 5 años en pacientes tratados quirúrgicamente para adenocarcinoma gástrico avanzado (T3, T4 y / o N + y / o con citología peritoneal positiva), tratados con gastrectomía curativa y HIPEC adyuvante o con gastrectomía curativa sola.
    E.2.2Secondary objectives of the trial
    Compare 3-year and 5-year recurrence-free survival;
    - Study the incidence of locoregional recurrence and compare locoregional recurrence-free 5-year survival;
    - Assess and compare treatment-related toxicity (Common Terminology Criteria for Adverse Events v4.0);
    - Compare sites of recurrence;
    - Identify prognostic factors of overall 5-year survival and recurrence-free 5-year survival;
    - Compare patients’ quality of life at preoperative time, M3, M6 and M12 and changes of quality of life
    Comparar la supervivencia sin recurrencia a los 3 y los 5 años;
    - Estudiar la incidencia de recurrencia locorregional y comparar la supervivencia locorregional libre de 5 años de supervivencia;
    - Evaluar y comparar la toxicidad relacionada con el tratamiento (Criterios Terminológicos Comunes para Eventos Adversos v4.0);
    - Comparar sitios de recurrencia;
    - Identificar los factores pronósticos de la supervivencia global a 5 años y de la supervivencia libre de recidiva a los 5 años;
    - Comparar la calidad de vida de los pacientes en tiempo preoperatorio, M3, M6 y M12 y cambios en la calidad de vida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demography
    I 01 18 < age ≤ 75 years old
    Health Status
    I 02. White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
    I 03. Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
    I 04. Performance Status ≤1, Karnofsky Index ≥ 70% (Appendix 5)
    I 05. Serum bilirubin ≤ 2 mg/dl
    Regulatory
    I 06. Having given written informed consent prior to any procedure related to the study.
    I 07. Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
    I 08. Not under any administrative or legal supervision
    Specific to the study
    I 09. Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia (Appendix 6)
    I 10 Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
    AND/OR
    I Females of childbearing age potential and male subjects with partners of childbearing potential using highly effective* contraceptive measures (according to CTFG recommendations). According to the clinical trial facilitation group recommendations, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to: - 4 months after the treatment with Oxaliplatin for female subjects, - 6 months after the treatment with Oxaliplatin for male subjects.

    * Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence.
    Demografía
    I 01 18 <edad ≤ 75 años de edad
    Estado de salud
    I 02. Glóbulos blancos> 3.500 / mm3, neutrófilos ≥ 1.500 / mm3, plaquetas ≥ 100.000 / mm3
    I 03. Buenas funciones renales, valores de creatinina sérica <1,5 mg / dl y aclaramiento de creatinina> 60 ml / min
    I 04. Estado de desempeño ≤1, índice de Karnofsky ≥ 70% (Apéndice 5)
    I 05. La bilirrubina sérica ≤ 2 mg / dl
    Regulador
    I 06. Haber dado su consentimiento informado por escrito antes de cualquier procedimiento relacionado con el estudio.
    I 07. Cubierto por un Sistema de Salud donde sea aplicable, y / o en cumplimiento de las recomendaciones de las leyes nacionales vigentes relativas a la investigación biomédica
    I 08. No bajo ninguna supervisión administrativa o legal
    Específicas para el estudio
    I 09. Adenocarcinoma gástrico y / o adenocarcinoma gástrico perforado y / o adenocarcinoma Siewert III de la cardia (Apéndice 6)
    I 10 Prueba histológica de T3 o T4 resecable para la cual se ha programado una gastrectomía curativa, con invasión a la serosa AND / OR metástasis ganglionar (determinada a partir de datos obtenidos por ecografía endoscópica y tomografía computarizada de tórax, abdomen y pelvis) Y / O citología peritoneal positiva (Muestreadas durante la laparoscopia preoperatoria).
    Y / o
    I 11. Mujeres en edad de procrear y sujetos masculinos con parejas potenciales de procrear utilizando medidas anticonceptivas altamente eficaces (según recomendaciones del CTFG). Según las recomendaciones del grupo de facilitación del ensayo clínico, se considera que una mujer es potencialmente fértil (WOCBP), después de la menarquia y hasta que se convierte en posmenopáusica, a menos que esté permanentemente estéril. Los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral. Un estado posmenopáusico se define como ausencia de menstruación durante 12 meses sin una causa médica alternativa. Los sujetos asignados al azar en el brazo con HIPEC deben ser informados y aceptar que estos requisitos también deben extenderse a:
    - 4 meses después del tratamiento con oxaliplatino para las mujeres,
    - 6 meses después del tratamiento con oxaliplatino para sujetos varones.

    * Estos métodos incluyen: anticoncepción hormonal combinada (estrógeno y progestágeno) asociada con la inhibición de la ovulación (oral, intravaginal, transdérmica) anticoncepción hormonal asociada a la inhibición de la ovulación (oral, inyectable, implantable), dispositivo intrauterino (DIU) Sistema de liberación de hormona intrauterina (IUS), oclusión tubárica bilateral, pareja vasectomizada, abstinencia sexual.
    E.4Principal exclusion criteria
    Medical history and clinical status
    E 01. Prior malignant tumors with detectable signs of recurrence
    E 02. Gastric stump adenocarcinoma
    E 03. Presence of comorbidities, notably serious chronic diseases or organ failure (> ASA 3)
    E 04. Peripheral neuropathy grade of ≥ 3 (CTC-AE V4.0) (if appropriate)
    General conditions
    E 05. Any subject in exclusion period of a previous study according to applicable regulations
    E.06. Pregnancy or breastfeeding
    E.07. Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
    GASTRICHIP – Protocol Version n°11 2016-05-11 Page 17 / 61
    Interfering substance
    E 08. Contraindication to any drug contained in the chemotherapy régimen. Oxaliplatin is specifically contraindicated if:
     known history of hypersensitivity to oxaliplatin or to its excipients.
     myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2x109/l and/or platelet count of <100x109/l.
     peripheral sensitive neuropathy with functional impairment prior to first course.
     severely impaired renal function (creatinine clearance less than 30 ml /min).

    Specific to the study
    E 09. Life threatening toxicity before surgery
    E 10. Distant metastases (liver, lung, ovaries, etc)
    E 11. Tumoral infiltration of the head or body of the pancreas
    E 12. Patients presenting an adenocarcinoma of the cardia Siewert I or II
    E 13. Existence of macroscopic peritoneal implants
    E 14. Patients with clinically significant ascites (> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
    Historial médico y estado clínico
    E 01. Tumores malignos previos con signos detectables de recurrencia
    E 02. Adenocarcinoma de muñón gástrico
    E 03. Presencia de comorbilidades, en particular enfermedades crónicas graves o insuficiencia orgánica (> ASA 3)
    E 04. Grado de neuropatía periférica ≥ 3 (CTC-AE V4.0) (si procede)
    Condiciones generales
    E 05. Cualquier sujeto en periodo de exclusión de un estudio previo de acuerdo con la normativa aplicable
    E.06. Embarazo o lactancia
    E.07. Las mujeres en edad de procrear potenciales o sujetos masculinos con parejas en edad fértil que no utilizan medidas anticonceptivas médicamente aceptadas, según lo juzgado por el investigador
    GASTRICHIP - Protocolo Versión n ° 11 2016-05-11 Página 17/61
    Sustancia interferente
    E 08. Contraindicación a cualquier fármaco contenido en el régimen de quimioterapia. Oxaliplatino está específicamente contraindicado si:
    - existe historia conocida de hipersensibilidad al oxaliplatino o a sus excipientes.
    - mielosupresión antes de comenzar el primer curso, como lo demuestran los neutrófilos basales <2x109 / l y / o recuento de plaquetas <100x109 / l.
    -neuropatía sensible periférica con deterioro funcional antes del primer curso.
    - insuficiencia renal grave (depuración de creatinina inferior a 30 ml / min).
    Específicas para el estudio
    E 09. Toxicidad potencialmente mortal antes de la cirugía
    E 10. Metástasis distantes (hígado, pulmón, ovarios, etc.)
    E 11. Infiltración tumoral de la cabeza o del cuerpo del páncreas
    E 12. Pacientes que presentan un adenocarcinoma de la cardia Siewert I o II
    E 13. Existencia de implantes macroscópicos peritoneales
    E 14. Pacientes con ascitis clínicamente significativo (> 500 cc) incluso si la citología es negativa para las células cancerosas, en ausencia de otras causas no malignas de ascitis










    Historial médico y estado clínico
    E 01. Tumores malignos previos con signos detectables de recurrencia
    E 02. Adenocarcinoma de muñón gástrico
    E 03. Presencia de comorbilidades, en particular enfermedades crónicas graves o insuficiencia orgánica (> ASA 3)
    E 04. Grado de neuropatía periférica ≥ 3 (CTC-AE V4.0) (si procede)
    Condiciones generales
    E 05. Cualquier sujeto en periodo de exclusión de un estudio previo de acuerdo con la normativa aplicable
    E.06. Embarazo o lactancia
    E.07. Las mujeres en edad de procrear potenciales o sujetos masculinos con parejas en edad fértil que no utilizan medidas anticonceptivas médicamente aceptadas, según lo juzgado por el investigador
    GASTRICHIP - Protocolo Versión n ° 11 2016-05-11 Página 17/61
    Sustancia interferente
    E 08. Contraindicación a cualquier fármaco contenido en el régimen de quimioterapia
    Específicas para el estudio
    E 09. Toxicidad potencialmente mortal antes de la cirugía
    E 10. Metástasis distantes (hígado, pulmón, ovarios, etc.)
    E 11. Infiltración tumoral de la cabeza o del cuerpo del páncreas
    E 12. Pacientes que presentan un adenocarcinoma de la cardia Siewert I o II
    E 13. Existencia de implantes macroscópicos peritoneales
    E 14. Pacientes con ascitis clínicamente significativo (> 500 cc) incluso si la citología es negativa para las células cancerosas, en ausencia de otras causas no malignas de ascitis
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival will be measured from the date of surgery to the date of death or to the end of follow-up (5 years).
    La supervivencia general se medirá desde la fecha de la cirugía hasta la fecha de la muerte o hasta el final del seguimiento (5 años).
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    5 años
    E.5.2Secondary end point(s)
    3.2.1 Efficacy
    - Three-year and 5-year recurrence-free survivals will be measured from the date of surgery to the date of recurrence or to the end of follow-up (death will be censored).
    - Will be considered as recurrence:
    - Peritoneal recurrence proven by pathology or cases of clinical evidence (palpable nodules, nodules visible on morphologic exams with significant increased tumor markers);
    GASTRICHIP – Protocol Version n°11 2016-05-11 Page 15 / 61
    - Locoregional recurrence proven by biopsies of lymph node and/or visible nodules;
    - Metastatic recurrence (evidence on morphologic exams or proved by pathology).
    - Locoregional recurrence will be listed. Five-year locoregional-free survival will be measured from the date of surgery to the date of locoregional recurrence or to the end of follow-up (death and other recurrences will be censored).
    - Site of recurrence will be classified into 3 groups:
    - Peritoneal;
    - Lymph nodes;
    - Metastatic (liver, lung, bones).
    3.2.2 Safety
    - Potential treatment-related toxicity (CTC-AE V4.0) (Appendix 2) (during the 60th postoperative days)
    - Potential treatment-related mortality (during the 60th postoperative days)
    - Treatment related morbidity (CTC-AE V4.0) with postoperative complications (during the 60th postoperative days)
    - Surgical complications:
    - Abdominal complications (Grade III and IV - CTC-AE V4.0): digestive fistula, intraperitoneal abscess, intraperitoneal haemorrhage, percutaneous drainage, pancreatatis;
    - Extra-abdominal complications (Grade III and IV - CTC-AE V4.0): pulmonary, urinary infection, catheter infection, thromboembolic, renal insufficiency, cardiac failure;
    - Postoperative aplasia (Grade III and IV - CTC-AE V4.0).
    - Serious adverse events:
    - Deaths during the 60th postoperative days;
    - Severe haemorrhage (Grade III and IV - CTC-AE V4.0);
    - Severe hemodynamic failure (Grade III and IV - CTC-AE V4.0);
    - All visceral failure: renal insufficiency necessitate dialysis, respiratory failure needed respiratory assistance, liver failure (bilirubin >10N), brain failure;
    - Home parenteral nutrition more than 1 month;
    - All infectious complications (intra-abdominal abscess);
    - Grade 4 thrombopenia (<25,000), neutropenia (<500 PN), transfusion (more than 4 RBCU);
    - Diarrhea > 15 stools per day after 21 days;
    - All adverse effect affecting life prognosis or leading to permanent or temporary serious incapacity.
    - Every death or complication of grade III/IV of the Common Toxicity Criteria (CTC-AE V4.0) of the National Cancer Institute occurring within 60 days of surgery will be an event for the analysis of postoperative morbidity and mortality. Complications of Grade 3 are those that require special treatment invasive (surgery, drainage, interventional radiology of the gesture) or readmission to hospital. Complications of Grade 4 will be those that require a shift in Intensive Care Unit ICU (presence of at least two organ failure in a broad sense).
    3.2.3 Quality of life
    Each patient’s quality of life will be assessed in the week preceding surgery, and at three months, six months and twelve months after the date of the first surgery.
    The EORTC questionnaires QLQ-C30 and QLQ-STO 22 designed for patients with gastric cancer undergoing a gastrectomy will be used (Appendix 3).
    3.2.1 Eficacia
    - Las supervivencias sin recurrencia de tres y cinco años se medirán desde la fecha de la cirugía hasta la fecha de la recurrencia o hasta el final del seguimiento (la muerte será censurada).
    - Se considerará como recurrencia:
    - Recurrencia peritoneal comprobada por patología o casos de evidencia clínica (nódulos palpables, nódulos visibles en los exámenes morfológicos con marcadores tumorales significativamente incrementados);
    GASTRICHIP - Protocolo Versión n ° 11 2016-05-11 Página 15/61
    - Recurrencia locorregional probada por biopsias de nódulos linfáticos y / o nódulos visibles;
    - Recurrencia metastásica (evidencia en exámenes morfológicos o comprobada por patología).
    - Se mostrará la recurrencia locorregional. La supervivencia libre de locorregional a los cinco años se medirá desde la fecha de la cirugía hasta la fecha de recurrencia locorregional o hasta el final del seguimiento (la muerte y otras recurrencias serán censuradas).
    - El sitio de recurrencia se clasificará en 3 grupos:
    - Peritoneal;
    - ganglios linfáticos;
    - Metastásico (hígado, pulmón, huesos).
    3.2.2 Seguridad
    - Toxicidad potencial relacionada con el tratamiento (CTC-AE V4.0) (Apéndice 2) (durante el 60º día postoperatorio)
    - Mortalidad potencial relacionada con el tratamiento (durante el 60º día postoperatorio)
    - Morbilidad relacionada con el tratamiento (CTC-AE V4.0) con complicaciones postoperatorias (durante el 60º día postoperatorio)
    - Complicaciones quirúrgicas:
    - Complicaciones abdominales (Grado III y IV - CTC-AE V4.0): fístula digestiva, absceso intraperitoneal, hemorragia intraperitoneal, drenaje percutáneo, pancreatatis;
    - Complicaciones extraabdominal (Grado III y IV - CTC-AE V4.0): infección pulmonar, urinaria, infección por catéter, tromboembolismo, insuficiencia renal, insuficiencia cardíaca;
    - Aplasia postoperatoria (Grado III y IV - CTC-AE V4.0).
    - Efectos adversos graves:
    - Muertes durante los 60 días postoperatorios;
    - Hemorragia grave (Grado III y IV - CTC-AE V4.0);
    - Insuficiencia hemodinámica severa (Grado III y IV - CTC-AE V4.0);
    - Todos los fallos viscerales: insuficiencia renal requieren diálisis, insuficiencia respiratoria, asistencia respiratoria, insuficiencia hepática (bilirrubina> 10 N), insuficiencia cerebral;
    - Nutrición parenteral en el hogar por más de 1 mes;
    - Todas las complicaciones infecciosas (absceso intraabdominal);
    - Trombopenia de grado 4 (<25.000), neutropenia (<500 PN), transfusión (más de 4 RBCU);
    - Diarrea> 15 heces por día después de 21 días;
    - Todo efecto adverso que afecte al pronóstico de la vida o que dé lugar a una incapacidad grave permanente o temporal.
    - Cada muerte o complicación de grado III / IV del Criterio Común de Toxicidad (CTC-AE V4.0) del Instituto Nacional del Cáncer que ocurra dentro de los 60 días de la cirugía será un evento para el análisis de la morbimortalidad postoperatoria. Las complicaciones de grado 3 son aquellas que requieren un tratamiento especial invasivo (cirugía, drenaje, radiología intervencionista del gesto) o readmisión al hospital. Las complicaciones de grado 4 serán aquellas que requieren un cambio en la UCI de la Unidad de Cuidados Intensivos (presencia de al menos dos fallas orgánicas en un sentido amplio).
    3.2.3 Calidad de vida
    La calidad de vida de cada paciente se evaluará en la semana anterior a la cirugía ya los tres meses, seis meses y doce meses después de la fecha de la primera cirugía.
    Se utilizarán los cuestionarios de la EORTC QLQ-C30 y QLQ-STO 22 diseñados para pacientes con cáncer gástrico sometidos a gastrectomía (Apéndice 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    5 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sólo cirugía
    Only surgery
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    5 years after last patient recruited
    5 años tras la finalización del último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 42
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 322
    F.4.2.2In the whole clinical trial 322
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment
    Tratamiento habitual
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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