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    Summary
    EudraCT Number:2019-004679-37
    Sponsor's Protocol Code Number:GECOP-MMC
    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:2024-04-23
    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 number2019-004679-37
    A.3Full title of the trial
    Phase IV multicentric clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with Mytomicin-C after complete surgical cytoreduction in patients with Colon Cancer Peritoneal Metastases
    Ensayo Clínico Multicéntrico Fase IV para evaluar la eficacia de la quimioterapia intraoperatoria hipertérmica (HIPEC) con Mitomicina-C tras la citorreducción quirúrgica completa en pacientes con Metástasis Peritoneales de Cáncer de Colon
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Surgical resection combined with intraperitoneal chemotherapy (CT) is the best treatment for selected patients with Peritoneal Metastases from colon cancer. However, the real role of intraperitoneal CT as a necessary component of this treatment is unknown, despite its proven experimental basis. The main objective of this study is to clarify it, so one group of patients will be treated with surgery + intraperitoneal CT and the other with surgery alone.
    La resección quirúrgica combinada con quimioterapia (QT) intraperitoneal es el mejor tratamiento para pacientes seleccionados con metástasis peritoneales de cáncer de colon. Sin embargo, se desconoce el papel real de la QT intraperitoneal como componente necesario de este tratamiento, a pesar de su probada base experimental. El objetivo principal de este estudio es aclararlo, por lo que un grupo de pacientes será tratado con cirugía + QT intraperitoneal y el otro solo con cirugía.
    A.3.2Name or abbreviated title of the trial where available
    Phase IV Clinical Trial on HIPEC with Mytomicin-C in Colon Cancer Peritoneal Metastases
    Ensayo Clínico Fase IV sobre HIPEC con Mitomicina-C en Metástasis Peritoneales de Cáncer de Colon
    A.4.1Sponsor's protocol code numberGECOP-MMC
    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 SponsorHospital Universitario de Fuenlabrada
    B.1.3.4CountrySpain
    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 supportIdiPAZ - Instituto de Investigación Hospital Universitario La Paz.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de Fuenlabrada
    B.5.2Functional name of contact pointÁrea de Investigación
    B.5.3 Address:
    B.5.3.1Street AddressCº del Molino 2
    B.5.3.2Town/ cityFuenlabrada
    B.5.3.3Post code28942
    B.5.3.4CountrySpain
    B.5.6E-mailmariapaz.iglesias@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Mitomycin-C
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL, S.L.U.
    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 nameMitomycin-C
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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.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
    Surgical resection combined with intraperitoneal chemotherapy (CT) is the best treatment for selected patients with Peritoneal Metastases from colon cancer. However, the real role of intraperitoneal CT as a necessary component of this treatment is unknown, despite its proven experimental basis. The main objective of this study is to clarify it, so one group of patientes will be treated with surgery + intraperitoneal CT and the other with surgery alone.
    La resección quirúrgica combinada con quimioterapia (QT) intraperitoneal es el mejor tratamiento para pacientes seleccionados con metástasis peritoneales de cáncer de colon. Sin embargo, se desconoce el papel real de la QT intraperitoneal como componente necesario de este tratamiento, a pesar de su probada base experimental. El objetivo principal de este estudio es aclararlo, por lo que un grupo de pacientes será tratado con cirugía + QT intraperitoneal y el otro solo con cirugía.
    E.1.1.1Medical condition in easily understood language
    Treatment of colon cancer peritoneal metastases with complete surgical resection combined or not with intraperitoneal hyperthermic intraoperative chemotherapy
    Tratamiento de las metástasis peritoneales de cáncer de colon con resección quirúrgica completa combinada o no con quimioterapia intraoperatoria hipertémica intraperitoneal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To assess whether there are differences in PERITONEAL RECURRENCE in patients with peritoneal metastases from colon cancer treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) intraoperative hyperthermic intraperitoneal chemotherapy
    Evaluar si existen diferencias en la RECURRENCIA PERITONEAL en pacientes con metástasis peritoneales de cáncer de colon tratados con resección quirúrgica completa y quimioterapia sistémica, con (Grupo 1) o sin (Grupo 2) quimioterapia intraperitoneal hipertérmica intraoperatoria
    E.2.2Secondary objectives of the trial
    - Evaluate if there are differences in recurrence at other levels between both groups (Disease-Free Survival)
    - Evaluate the toxicity of the treatments and compare the postoperative complications between both groups
    - Determine prognostic factors for peritoneal recurrence and at other locations
    - Compare the overall survival between both groups
    - Study of the Quality of Life in both groups using the QLQ-C30 and QLQ-CR29 questionnaires of the EORTC
    - Evaluar si existen diferencias en la recurrencia a otros niveles entre ambos grupos (supervivencia libre de enfermedad)
    - Evaluar la toxicidad de los tratamientos y comparar las complicaciones postoperatorias entre ambos grupos
    - Determinar factores pronósticos de recurrencia peritoneal y en otras localizaciones.
    - Comparar la supervivencia global entre ambos grupos
    - Estudio de la Calidad de Vida en ambos grupos mediante los cuestionarios QLQ-C30 y QLQ-CR29 de la EORTC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically confirmed colon cancer, except those with signet ring cells (> 50% of the tumor composed of these cells, only 1% of CRCs)
    2) Absence of extraperitoneal metastases, including distant lymphadenopathy, liver and lung metastases (ruled out by PET in case of doubt).
    3) Mild or moderate extent synchronous or metachronous peritoneal carcinomatosis with a PCI ≤ 20 (intraoperative confirmation)
    4) Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation)
    5) Treatment with perioperative systemic chemotherapy (before and/or after surgical procedure).
    6) Age> 18 years
    7) Acceptable anesthetic/surgical risk: ASA 1-3, ECOG 0-1. No severe alterations in hematological, renal and hepatic function (operable patients)
    8) Information to the patient and signing of a study-specific informed consent
    1) Cáncer de colon confirmado histológicamente, excepto aquellos con células en anillo de sello (> 50% del tumor compuesto por estas células, solo 1% de CCR)
    2) Ausencia de metástasis extraperitoneales, incluyendo adenopatías a distancia, metástasis hepáticas y pulmonares (descartadas mediante PET en caso de duda).
    3) Carcinomatosis peritoneal sincrónica o metacrónica de grado leve o moderado con PCI ≤ 20 (confirmación intraoperatoria)
    4) Obtención de una citorreducción quirúrgica macroscópicamente completa CCS-0 (confirmación intraoperatoria)
    5) Tratamiento con quimioterapia sistémica perioperatoria (antes y / o después del procedimiento quirúrgico).
    6) Edad> 18 años
    7) Riesgo anestésico/quirúrgico aceptable: ASA 1-3, ECOG 0-1. Sin alteraciones graves de la función hematológica, renal y hepática (pacientes operables)
    8) Información al paciente y firma de un consentimiento informado específico del estudio
    E.4Principal exclusion criteria
    1) Carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell CC on histology.
    2) No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
    3) High volume peritoneal carcinomatosis, with a PCI> 20 (intraoperative evaluation).
    4) Concurrent or previously treated extraperitoneal disease.
    5) Progression during preoperative chemotherapy, if received.
    6) Patients previously treated with HIPEC.
    7) History of other cancers (except cutaneous basal cell carcinoma or cervical carcinoma in situ) in the 5 years prior to entry into the study.
    8) Patient included in another first-line clinical trial for the disease studied.
    9) Pregnancy (or suspected of it) or lactation period.
    10) Urgent intervention for obstruction or perforation.
    11) Persons deprived of liberty or under guardianship.
    12) Inability to understand the nature of the intervention, the risks, benefits, expected evolution and the need to undergo periodic medical examinations, either for geographical, social or psychological reasons.
    1) Carcinomatosis de cualquier otro origen, en particular el cáncer de recto o el adenocarcinoma apendicular, o CC de células en anillo de sello en la histología.
    2) No confirmación intraoperatoria de enfermedad peritoneal (PCI 0). Igualmente se excluirán los casos de recidivas perianastomóticas (locales) o ganglionares (locorregionales).
    3) Carcinomatosis peritoneal de alto volumen, con un PCI > 20 (evaluación intraoperatoria).
    4) Enfermedad extraperitoneal simultánea o tratada previamente.
    5) Progresión durante la quimioterapia preoperatoria, en caso de recibirla.
    6) Pacientes tratados previamente con HIPEC.
    7) Antecedente de otros cánceres (excepto el carcinoma basocelular cutáneo o carcinoma in situ de cuello uterino) en los 5 años previos a la entrada en el estudio.
    8) Paciente incluido en otro ensayo clínico de primera línea para la enfermedad estudiada.
    9) Embarazo (o sospecha del mismo) o periodo de lactancia.
    10) Intervención urgente por obstrucción o perforación.
    11) Personas privadas de libertad o bajo tutela.
    12) Incapacidad para comprender la naturaleza de la intervención, los riesgos, beneficios, evolución esperada y necesidad de someterse a exámenes médicos periódicos, ya sea por razones geográficas, sociales o psicológicas.
    E.5 End points
    E.5.1Primary end point(s)
    Peritoneal Recurrence Free Survival at 1 and 2 years.
    Supervivencia libre de recurrencia peritoneal a 1 y 2 años.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 2 years after treatment with surgery +/- intraoperative hyperthermic intraperitoneal chemotherapy
    1 y 2 años después del tratamiento con cirugía +/- quimioterapia intraperitoneal hipertérmica intraoperatoria
    E.5.2Secondary end point(s)
    - Disease-Free Survival in both groups at 1 and 2 years (Variables: Global, locoregional and distant recurrence [isolated, coincident or simultaneous with peritoneal recurrence]
    - Toxicity of the treatments in both groups (Variable: Postoperative complications using the CTCAE v5.0 adverse event classification system)
    - Prognostic factors for peritoneal recurrence and at other locations (Variables:
    synchronous/metachronous peritoneal metastases, perioperative SCT, use of biological agents or immunotherapy, stratified PCI (<11, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability, and degree of peritoneal tumor regression).
    - Overall survival in both groups at 1 and 2 years
    - Quality of Life in both groups
    - Supervivencia libre de enfermedad en ambos grupos a 1 y 2 años (Variables: recurrencia global, locorregional y a distancia [aislada, coincidente o simultánea con recurrencia peritoneal]
    - Toxicidad de los tratamientos en ambos grupos (Variable: Complicaciones postoperatorias utilizando el sistema de clasificación de eventos adversos CTCAE v5.0)
    - Factores pronósticos de recidiva peritoneal y en otras localizaciones (Variables:
    metástasis peritoneales sincrónicas/metacrónicas, quimioterapia perioperatoria, uso de agentes biológicos o inmunoterapia, PCI estratificado (<11, 11-15, 16-20), complicaciones postoperatorias, colon derecho/izquierdo, grado de diferenciación, invasión vascular/linfática/ erineural, Estado RAS/RAF, inestabilidad de microsatélites y grado de regresión tumoral peritoneal).
    - Supervivencia global en ambos grupos a 1 y 2 años
    - Calidad de vida en ambos grupos
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Disease-Free Survival: at FOLLOW-UP visits AFTER DISCHARGE (1 month, 4 months, 8 months, 12 months, 18 months and 24 months)
    - Toxicity (Variable: Postoperative complications at 90 days, including those related to HIPEC).
    - Prognostic factors for peritoneal recurrence and at other locations (some obtained before surgical intervention, and some perioperative)
    - Overall survival: at FOLLOW-UP visits AFTER DISCHARGE (1 month, 4 months, 8 months, 12 months, 18 months and 24 months)
    - Quality of Life (QLQ-C30 and QLQ-CR29 questionnaires of the EORTC before surgical intervention, at first visit after surgery, at the end of SCT and during subsequent follow-up at 12, 18 and 24 months.
    - Supervivencia libre de enfermedad: en las visitas de SEGUIMIENTO DESPUÉS DEL ALTA (1 mes, 4 meses, 8 meses, 12 meses, 18 meses y 24 meses)
    - Toxicidad (Variable: Complicaciones postoperatorias a los 90 días, incluidas las relacionadas con HIPEC).
    - Factores pronósticos de recidiva peritoneal y en otras localizaciones (algunos obtenidos antes de la intervención quirúrgica y otros perioperatorios)
    - Supervivencia global: en las visitas de SEGUIMIENTO DESPUÉS DEL ALTA (1 mes, 4 meses, 8 meses, 12 meses, 18 meses y 24 meses)
    - Calidad de vida (cuestionarios QLQ-C30 y QLQ-CR29 de la EORTC antes de la intervención quirúrgica, en la primera visita tras la cirugía, al final del TCM y durante el seguimiento posterior a los 12, 18 y 24 meses).
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    cirugía sin quimioterapia intraperitoneal
    surgery without intraperitoneal chemotherapy
    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 concerned29
    E.8.5The trial involves multiple Member States No
    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
    last visit of the last subject recruited in the trial
    última visita del último sujeto reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state216
    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)
    Not different from the expected normal treatment of that condition
    No es diferente del tratamiento normal esperado de esa condición.
    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 Decision2021-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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