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    Summary
    EudraCT Number:2019-002074-32
    Sponsor's Protocol Code Number:IFOM-CPT005/2019/PO004
    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:2019-11-11
    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 number2019-002074-32
    A.3Full title of the trial
    POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS
    TRATAMIENTO POSTQUIRÚRGICO GUIADO POR BIOPSIA LÍQUIDA DE PACIENTES CON CÁNCER DE COLON EN ESTADIO III Y ESTADIO II DE ALTO RIESGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF COLON CANCER PATIENTS
    TRATAMIENTO POSTQUIRÚRGICO GUIADO POR BIOPSIA LÍQUIDA DE PACIENTES CON CÁNCER DE COLON
    A.3.2Name or abbreviated title of the trial where available
    PEGASUS trial
    Ensayo PEGASUS
    A.4.1Sponsor's protocol code numberIFOM-CPT005/2019/PO004
    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 SponsorIFOM - Istituto FIRC di Oncologia Molecolare
    B.1.3.4CountryItaly
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFOM - Istituto FIRC di Oncologia Molecolare
    B.5.2Functional name of contact pointPrecision Oncology Unit
    B.5.3 Address:
    B.5.3.1Street AddressVia Adamello 16
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902574303862
    B.5.6E-mailsilvia.marsoni@ifom.eu
    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.2.1.2Country 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 namecapecitabine
    D.3.2Product code capecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITIABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeCAPECITIABINE
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 500
    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 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.2.1.2Country 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 nameoxaliplatinum
    D.3.2Product code oxaliplatinum
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor codeOXA
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 250
    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 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.2.1.2Country 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-FU
    D.3.2Product code 5-FU
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUOROURACIL
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-FU
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 1000
    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: 4
    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.2.1.2Country 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 nameIrinotecan
    D.3.2Product code IRI
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.1CAS number 136572-09-3
    D.3.9.2Current sponsor codeIrinotecan
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB45873
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 300
    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: 5
    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.2.1.1.2Name of the Marketing Authorisation holder67128
    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 nameLeucovorin
    D.3.2Product code Leucovorin
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUCOVORIN
    D.3.9.2Current sponsor codeLV
    D.3.9.3Other descriptive nameCALCIUM FOLINATE
    D.3.9.4EV Substance CodeSUB06052MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Stage III and high-risk stage II colon cancer
    Cáncer de color en estadio III y estadio II de alto riesgo
    E.1.1.1Medical condition in easily understood language
    Colon cancer
    Cáncer de colon
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to study the feasibility of using liquid biopsy to guide the
    post-surgical and post-adjuvant clinical management of stage III and high-risk stage
    II (T4N0) MSS colon cancer patients.
    Feasibility is defined as the ability of at least two subsequent negative ctDNA
    determination to identify patients that will be NED (without radiologic evidence of
    metastasis) 2 years aftersurgery
    El objetivo primario es estudiar la factibilidad del uso de biopsias líquidas para guiar el manejo clínico post-quirúrgico y post-adyuvante de pacientes con cáncer de colon en estadío III y estadío II de alto riesgo (T4N0).
    Factibilidad se define como la capacidad de utilizar el resultado negativo de de ctDNA en al menos 2 biopsias líquidas para identificar pacientes que estarán NED, es decir, libres de evidencia radiológica de metástasis, 2 años después de la cirugía.
    E.2.2Secondary objectives of the trial
    - To compare the DFS and OS rates at 2,3 and 5 years in a cohort of 140 stage III and
    high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with
    a LB guided strategy, with the DFS and OS rates of a 1:3 phenotypically matched cohort
    of the TOSCA trial treated with FOLFOX/CAPOX either at 3 or 6 months.
    • To compare the safety profile in a cohort of 140 stage III and high-risk stage II
    (only T4N0) MSS colon cancer patients treated with a liquid biopsy-guided strategy,
    with the safety profile of 1:3 phenotypically matched cohort of the TOSCA trial
    treated with FOLFOX/CAPOX at 3 or 6 months. • To validate LB seroconversion as a proxy of therapy efficacy and to compare its
    performance with CEA testing
    whenever CEA levels are above the normal values.
    • To study the QoL of patients in a cohort of 140 stage III and high-risk stage II
    (only T4N0) MSS colon cancer patients treated post-surgically with a liquid biopsyguided
    strategy
    - Comparar la ratio de Supervivencia Libre de Enfermedad (SLE) y Supervivencia Global (SG) a los 2, 3 y 5 años en 140 pacientes con cáncer de colon con estabilidad microsatelitar (CCEM) y estadío III o II de alto riesgo (T4N0), con la SLE y SG en una cohorte en proporción 1:3, emparejada por fenotipo y tratada con FOLFOX/CAPOX por 3 o 6 meses en el estudio TOSCA
    - Comparar el perfil de seguridad en 140 pacientes con CCEM y estadío III o II de alto riesgo (T4N0), tratados post-cirugía con una estrategia guiada por biopsias líquidas, con el perfil de seguridad de una cohorte 1:3, emparejada por fenotipo y tratada con FOLFOX/CAPOX por 3 o 6 meses en el estudio TOSCA
    - Validar la negativización de la detección de ctDNA tras la administración de tratamiento como indicador de eficacia terapéutica y comparar su evolución con los valores de CEA en sangre en pacientes con niveles de CEA elevados
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pegasus trial written informed consent.
    2. Age = 18 years.
    3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon
    cancer located 12 cm from the anal verge by endoscopy and above the peritoneal
    reflection at surgery.
    4. Availability of plasma collected prior to surgery.
    5. Availability of the original FFPE tumor tissue.
    6. Acceptance to undergo at least all the interventional liquid biopsies.
    7. ECOG performance status 0-1.
    8. Normal organ functions. (as defined in section 9.3)
    9. Women with childbearing potential should complete a pregnancy test and be willing to
    use highly effective contraceptive
    1. Consentimiento informado escrito para el estudio PEGASUS
    2. Edad ≥ 18 años
    3. Diagnóstico histológicamente confirmado de cáncer de colon operable en estadío III o estadío II T4N0 localizado a 12 cm o más del margen anal por endoscopía y por encima del pliegue peritoneal en la cirugía.
    4. Disponibilidad de plasma recogido antes de la cirugía.
    5. Disponibilidad de los bloques tumorales FFPE.
    6. Consentir a por lo menos todas las biopsias líquidas intervencionales
    7. Performance status (ECOG) 0,1.
    8. Función normal de los órganos (como definidos en la sección 9.3).
    9. Las pacientes mujeres con potencial de gravidanza deben completar un test de embarazo y aceptar el uso de métodos contraceptivos de alta efectividad.
    E.4Principal exclusion criteria
    1. Patients having a MSI-H/MMRd tumor are excluded from the study (done according to
    standard clinical practice).
    2. History of another neoplastic disease, unless in remission for = 5 years.
    Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin,
    or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have
    undergone potentially curative therapy are not excluded.
    3. Had an incomplete diagnostic colonoscopy and/or polyps removal.
    4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients
    should never have had any evidence of metastatic disease (including presence of tumor
    cells in the peritoneal lavage).
    5. Current or recent treatment with another investigational drug or participation in
    another investigational study
    6. Patient unable to comply with the study protocol owing to psychological, social or
    geographical reasons.
    7. Is pregnant or breastfeeding, or expecting to conceive or father children within the
    projected duration of the study.
    8. Inadequate contraception (male or female patients) if of childbearing or
    procreational potential.
    9. Clinically relevant cardiovascular disease.
    10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
    11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of
    the components of the treatment.
    12. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
    13. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
    14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
    required.
    15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
    reactive)or known active Hepatitis C virus infection. Note: no testing for Hepatitis B
    and Hepatitis C isrequired unless mandated by local health authority.
    16. Has a known history of active TB (Bacillus
    1. Pacientes con tumores que expresan MSI-H/MMRd (diagnostico efectuado con tests clínicos estándar) son excluídas del estudio.
    2. Historia de otra enfermedad neoplásica a menos que esté en remisión por ≥ 5 años. Los pacientes con carcinoma basocelular de la piel, carcinoma escamoso de la piel o carcinomas in situ (por ejemplo cáncer de seno o carcinoma in situ del cuello uterino) que han recibido tratamiento potencialmente curativo no están excluídos.
    3. Pacientes que tuvieron una colonoscopía diagnóstica incompleta y/o remoción de pólipos incompleta.
    4. Evidencia macroscópica o microscópica de tumor residual (resecciones tipo R1 o R2). Los pacientes no deben haber tenido nunca evidencia de enfermedad metastática (que incluye presencia de células tumorales en el lavado peritoneal).
    5. Tratamiento actual o reciente con otra medicina investigacional o participación en otro estudio investigacional.
    6. Paciente incapaz de cumplir con los requerimientos del protocolo del estudio por motivos psicológicos, sociales o geográficos.
    7. Pacientes embarazadas o dando pecho, o que desean concebir o engendrar hijos durante el período proyectado de duración del estudio.
    8. Uso de métodos contraceptivos inadecuados (tanto los pacientes hombres como mujeres) si en edad con potencial de procrear.
    Enfermedad cardiovascular clínicamente relevante.
    9. Enfermedad cardiovascular clínicamente relevante
    10. Oclusión intestinal aguda o subaguda o historia de enfermedad inflamatoria intestinal.
    11. Historia de neuropatía > grado 1. Historia de reacciones alérgicas grado 3 o 4 a la administración de cualquiera de los components del tratamiento.
    12. Pacientes con sindromes de Gilbert o variante germinal homozigótica UGT1A1 *28/*28
    13. Historia conocida de deficiencia de DPD (DihydroPyrimidine Dehydrogenase).
    14. Historia de infección con Virus de la Inmunodeficiencia Humana (VIH). Nota: que no se requiere efectuar el test de VIH.
    15. Historia previa de Hepatitis B (definida como presencia de antigen de superficie de la hepatitis B [Hbs Ag] o que se sabe que presenta infección activa con el virus de la Hepatitis B. Nota: no se requiere realizar test de Hepatitis B ni de Hepatitis C a menos que sea un requerimiento de las autoridades locales.
    16. Historia conocida de infección tuberculosa activa (Bacilo de la Tuberculosis, TB).
    E.5 End points
    E.5.1Primary end point(s)
    Number of post-surgery and post-adjuvant false negative cases after a double ctDNAnegative
    detection, defined as cases that become positive at subsequent interventional
    LB or that experience radiological relapse within 2 years.
    Número de falsos negativos post-cirugía y post tratamiento adyuvante luego de una doble detección con resultados negativos para ctDNA, definido como casos que se hacen positivos en una siguiente BL intervencional o que experimentan recurrencia radiológica dentro de 2 años.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 2 years from surgery
    en los 2 años que siguen a la cirugía
    E.5.2Secondary end point(s)
    1- Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5-years.
    2- Safety and tolerability avvording to CTCAE version 4.03
    3- Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-)
    after any chemotherapy regimen remaining disease free at 2 and 3 years.
    4- Assessment of QLQ-C30 and CR-29 EORTC questionnaires
    1- Supervivencia libre de enfermedad a 2 y 3 años, Supervivencia Global a 5 años.
    2- Seguridad y tolerabilidad de acuerdo con CTCAE versión 5.0.
    3- Número de pacientes que muestran un seroconversión de ctDNA (es decir, que siendo ctDNA+ se transforman en ctDNA-) luego de cualquiera de los regímenes de quimioterapia y permanecen libres de enfermedad a 2 y 3 años.
    4- Evaluación de los cuestionarios QLQ-C30 y EORTC CR-29.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 2, 3 and 5 years
    2- the whole study
    3- at 2 and 3 years
    4- the whole study
    1- 2, 3 y 5 años
    2- durante todo el estudio
    3- a los 2 y 3 años
    4- durante todo el estudio
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility of using liquid biopsy to guide post-surgical and post-adjuvant
    clinical management of patients with colon cancer
    Factibilidad de usar la biopsia líquida para guiar el manejo clínico post-quirúrgico y post-adyuvante de pacientes con cáncer de colon.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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
    cohorte histórica del ensayo clínico TOSCA
    historical cohort of the TOSCA clinical trial
    E.8.2.4Number of treatment arms in the trial1
    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 EEA9
    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 No
    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
    LVLS
    LVLS (última visita del último paciente)
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    clinical standard therapies
    tratamiento clínico estándar
    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 Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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