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    Summary
    EudraCT Number:2018-003691-12
    Sponsor's Protocol Code Number:TUD-CIRC01-071
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-08-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003691-12
    A.3Full title of the trial
    Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE)
    AIO-KRK-0217
    Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE)
    AIO-KRK-0217
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE)
    AIO-KRK-0217
    Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE)
    AIO-KRK-0217
    A.3.2Name or abbreviated title of the trial where available
    CIRCULATE
    A.4.1Sponsor's protocol code numberTUD-CIRC01-071
    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 SponsorTechnische Universität Dresden
    B.1.3.4CountryGermany
    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 supportGerman Federal Ministry for Education and Research, German Aerospace Centre
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Fakultät Carl Gustav Carus der TU Dresden, Medizinische Klinik und Poliklinik I
    B.5.2Functional name of contact pointcoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number+493514584794
    B.5.5Fax number+49351458887666
    B.5.6E-mailCirculate-Study@ukdd.de
    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 AuthorisationEuropean Union
    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 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 INNCAPECITABINE
    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 typeequal
    D.3.10.3Concentration number500
    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
    Colon cancer stage II
    Dickdarmkrebs im Stadium II
    E.1.1.1Medical condition in easily understood language
    Colon cancer stage II
    Dickdarmkrebs im Stadium II
    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 10009954
    E.1.2Term Colon cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10038049
    E.1.2Term Rectal cancer stage II
    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
    To compare the disease free survival (DFS) with vs. without adjuvant chemotherapy in patients who are positive for ctDNA (ctDNApos) after the resection of the primary tumour .
    Vergleich des krankheitsfreien Überlebens (DFS) mit vs. ohne adjuvante Chemotherapie bei Patienten, die nach der Resektion des Primärtumors positiv für zirkulierende Tumor-DNA (ctDNApos) sind.
    E.2.2Secondary objectives of the trial
    a) to compare the overall survival in colon cancer patients stage II in ctDNA positive patients with and without chemotherapy
    b) to determine the disease free survival in ctDNA negative patients
    c) to determine the overall survival of ctDNA negative patients
    d) to compare the disease free and overall survival in patients without adjuvant therapy according to their ctDNA status
    e) to compare the site of metastases according to the way of metastases (heamato- vs lymphogenic vs. local/peritoneal) and ctDNA status
    f) to determine the chemotherapy safety.
    a) Vergleich des Gesamtüberlebens mit vs. ohne adjuvante Chemotherapie bei ctDNA-positiven Patienten
    b) Bestimmung des krankheitsfreien Überlebens (DFS) bei ctDNA-negativen Patienten
    c) Bestimmung des Gesamtüberlebens bei ctDNA-negativen Patienten
    d) Vergleich des krankheitsfreien Überlebens und des Gesamtüberlebens bei Patienten ohne Chemotherapie entsprechend ihres ctDNA-Status
    e) Vergleich der Metastasenlokalisationen nach dem Weg der Metastasierung (hämato- vs. lymphogen vs. peritoneal/Lokalrezidiv) entsprechend des ctDNA-Status
    f) Bestimmung der Chemotherapiesicherheit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for screening phase:
    1) Resected colon cancer stage II,
    OR
    Resected rectal cancer stage II, if there was no indication for
    radiotherapy (i.e. due to the localisation in the upper third of
    the rectum ), so that the treatment follows the recommenda-
    tions for colon cancer.
    Patients, in whom the tumour stage is not yet know, can be en-
    rolled into the screening.
    2) Signed informed consent for the screening phase

    Inclusion criteria for the randomised phase:
    1) Resected colon cancer stage II,
    OR resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum), so that the treatment follows the recommendations for colon cancer.
    2) Known microsatellite or mismatch repair status
    3) Confirmation, that the ctDNA result is available
    4) Signed second informed consent (for the randomised phase)
    Einschlusskriterien für die Screeningphase:
    1) Reseziertes Kolonkarzinom im Stadium II,
    ODER
    Reseziertes Rektumkarzinom im Stadium II, wenn keine Indikation zur Bestrahlung besteht (z.B. bei einer Lage im oberen Rektumdrittel), so dass die Behandlung der des Kolonkarzinoms entspricht.
    Patienten, bei denen das Stadium noch nicht bekannt ist, können in das Screening eingeschlossen werden.
    2) Unterzeichnete Einwilligungserklärung für das Screening

    Einschlusskriterien für die randomisierte Phase:
    1) Reseziertes Kolonkarzinom im Stadium II,
    ODER reseziertes Rektumkarzinom im Stadium II, wenn keine Indikation zur Bestrahlung besteht (z.B. bei einer Lage im oberen Rektumdrittel), sodass die Behandlung der des Kolonkarzinoms entspricht.
    2) Bekannter MSI- oder MMR- Status
    3) Bestätigung, dass das ctDNA Ergebnis verfügbar ist
    4) Unterzeichnete zweite Einwilligungserklärung (für die randomisierte Phase)
    E.4Principal exclusion criteria
    Exclusion criteria for Screening:
    1) Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
    2) Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
    3) Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, active second cancer or age). It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemotherapy.
    4) R1- or R2-status (patients with [still] unknown R-status can be screened)
    5) Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
    6) Age < 18 years
    7) Pregnant or breast feeding patients

    Exclusion criteria for randomised phase:
    1) Patients with microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
    2) Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
    3) R1- or R2- status, or unknown R- status (Rx)
    4) Number of investigated lymph nodes < 10
    5) WHO performance status ≥ 2
    6) Colon or rectal cancer with UICC stage III or IV
    7) Second cancer, except
    a. simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I,
    b. curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma
    c. tumours with a disease free survival of more than five years
    8) Contra indications for chemotherapy, especially:
    a. Leukocytes < 3,0 Gpt/l
    b. Neutrophil granulocytes < 1,5 Gpt/l
    c. Thrombocytes < 100 Gpt/l
    d. ALAT or ASAT > 3 x ULN
    e. Creatinine clearance (calculated according Cockcroft-Gault) < 30 ml/min
    9) Comorbidities relevantly interfering with the prognosis of the patients, i.e.:
    a. heart insufficiency NYHA III/IV
    b. relevant coronary heart disease,
    c. Diabetes mellitus with late sequelae
    10) Organ, stem cell or bone marrow transplantation
    11) Known hypersensitivity to capecitabine
    In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin
    12) Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start
    13) Known biallelic or homozygous dihydropyrimidine dehydrogenase (DPD)-deficiency
    14) Acute infections
    15) Known HIV- infections, known active hepatitis B or C-infection
    16) Participation at another interventional study for medical treatment during the last four weeks before randomisation
    17) Neoadjuvant therapy before resection
    18) Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
    19) Age < 18 years
    20) Pregnant or breast feeding patients
    21) Women of childbearing potential and men with partner with childbearing potential who are not willing to take appropriate precautions to avoid pregnancy with a highly effective method in case they are randomised to “chemotherapy”
    Ausschlusskriterien für das Screening:
    1) Patienten mit bekannter Mikrosatelliteninstabilität (MSI-H) oder Mismatch-repair-Defizienz (dMMR)
    2) Bekannte klinische Hochrisikosituation, wenn diese als sichere Indikation für eine adjuvante Therapie betrachtet wird
    3) Patienten, die eine offensichtliche Kontraindikation für eine adjuvante Chemotherapie haben (z.B. auf Grundlage des Allgemeinzustands, der Komorbidität, eines aktiven Zweittumors, des hohen Alters). Es soll dabei in Betracht gezogen werden, dass Patienten über 75 Jahre häufig nicht die Einschlusskriterien für eine adjuvante Chemotherapie erfüllen.
    4) R1- oder R2-Status (Patienten mit [noch] unbekanntem R-Status können in das Screening)
    5) Patienten, bei denen die Randomisation oder Chemotherapie aus logistischen Gründen nicht möglich ist (Anreiseweg, Compliance)
    6) Alter < 18 Jahre
    7) Schwangere oder stillende Patienten

    Ausschlusskriterien für die randomisierte Phase:
    1) Patienten mit Mikrosatelliteninstabilität (MSI-H) oder Mismatch-repair-Defizienz (dMMR)
    2) Bekannte klinische Hochrisikosituation, wenn diese als sichere Indikation für eine adjuvante Therapie betrachtet wird
    3) R1- oder R2-Status oder mit unbekanntem R-Status (Rx)
    4) Anzahl der untersuchten Lymphknoten < 10
    5) Allgemeinzustand nach WHO ≥ 2
    6) Kolon- oder Rektumkarzinom im Stadium III oder IV
    7) Zweitkarzinom, außer
    a. simultanes oder metachrones Kolon- oder Rektumkarzinom im UICC Stadium ≤ I,
    b. kurativ behandeltes Basalzellkarzinom oder Plattenepithelkarzinom der Haut oder in-situ Zervixkarzinom
    c. Tumor mit einem krankheitsfreien Überleben von mehr als fünf Jahren
    8) Kontraindikationen für eine Chemotherapie, insbesondere:
    a. Leukozyten < 3,0 Gpt/l
    b. Neutrophile Granulozyten < 1,5 Gpt/l
    c. Thrombozyten < 100 Gpt/l
    d. ALAT oder ASAT > 3 x obere Norm
    e. Kreatininclearance (berechnet nach Cockcroft-Gault) < 30 ml/min
    9) Begleiterkrankungen mit einem relevanten Einfluss auf die Prognose des Patienten, z.B.:
    a. Herzinsuffizienz NYHA III/IV
    b. relevante koronare Herzerkrankung,
    c. Diabetes mellitus mit Spätschäden
    10) Organ-, Stammzell- oder Knochenmarktransplantation
    11) Bekannte Überempfindlichkeit gegenüber Capecitabin. Bei einer bekannten Überempfindlichkeit gegen Oxaliplatin, können Patienten an der Studie teilnehmen, aber kein Oxaliplatin erhalten
    12) Medikation mit Brivudin, Sorivudin oder Analoga in den letzten vier Wochen vor geplantem Behandlungsstart
    13) Bekannter biallelischer oder homozygoter Dihydropyrimidin-Dehydrogenase (DPD)-Mangel
    14) Akute Infektionen
    15) Bekannte HIV- Infektionen, bekannte, aktive Hepatitis B oder C-Infektion
    16) Teilnahme an einer anderen interventionellen Studie mit medikamentöser Therapie in den letzten vier Wochen vor Randomisation
    17) Neoadjuvante Therapie vor Resektion
    18) Patienten, bei denen die Randomisation oder Chemotherapie
    aus logistischen Gründen nicht möglich ist (Anreiseweg, Compliance)
    19) Alter < 18 Jahre
    20) Schwangere oder stillende Patientinnen
    21) Gebärfähige Frauen und Männer mit gebärfähiger Partnerin, die nicht zu hoch effektiven Verhütungsmaßnahmen bereit sind, wenn sie in den Arm “Chemotherapie” randomisiert werden.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival of ctDNA positive patients randomised to “chemotherapy” vs. “follow-up”, measured from randomisation to any recurrence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
    Krankheitsfreies Überleben von ctDNA positiven Patienten, die in „Chemotherapie“ vs. die in „Nachsorge“ randomisiert wurden, gemessen von der Randomisation bis zum Zeitpunkt jeglichen Rezidivs, Metastasierung, Zweitkarzinom (kolorektales oder nicht-kolorektales Karzinom) oder Tod jedweder Ursache. Der primäre Endpunkt wird in allen randomisierten Patienten getestet, die positiv für ctDNA sind und mit einem stratifizierten Log-rank Test evaluiert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interims analysis after 93 events (approx. 38 months after study start),
    final analysis for the primary endpoint after 154 events (approx. 60 months after study start).
    Zwischenanalyse nach 93 Ereignissen (ca. 38 Monate nach Studienbeginn),
    finale Analyse in Bezug auf den primären Endpunkt nach 154 Ereignissen (ca. 60 Monate nach Studienstart).
    E.5.2Secondary end point(s)
    a) Overall survival in ctDNApos patients with adjuvant therapy vs follow-up, measured from randomisation to death from any cause, in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
    b) Disease free survival in ctDNAneg patients randomised to follow up (rate of patients disease free and alive 3 years after randomisation according to Kaplan-Meier estimation with 95% CI, intention-to-treat analysis). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause is regarded as event
    c) Overall survival in ctDNAneg patients randomised to “follow up” (rate of patients alive after 5 years after randomisation according to Kaplan-Meier estimation with 95% CI)
    d) Disease free and overall survival of ctDNApos vs. ctDNAneg patients randomized to „follow-up“ (measured from randomisation to the event in an intention-to-treat analysis by stratified log rank test). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause are regarded as event for DFS. Death of any cause will be regarded as event for overall survival.
    e) Site of metastases (lymph node vs. peritoneal/local recurrence vs other) in ctDNApos vs. ctDNAneg patients who have a recurrence / metastases
    f) Frequency of adverse events from start of chemotherapy until 30 days after chemotherapy (descriptive analysis for patients randomised to “chemotherapy” who have received at least one dose of chemotherapy).
    a) Gesamtüberleben bei ctDNApos Patienten mit Chemotherapie vs. Nachsorge, gemessen von der Randomisation bis zum Tod jeder Ursache, bei allen randomisierten ctDNA positiven Patenten und evaluiert mit einem stratifizierten Log-rank Test
    b) Krankheitsfreies Überleben bei ctDNAneg Patienten, die in Nachsorge randomisiert werden (Rate der Patienten, die 3 Jahre nach Randomisation entsprechend der Kaplan-Meier Schätzung krankheitsfrei und am Leben sind, mit 95% CI; Intention-to-Treat Analyse). Jedes Rezidiv, Metastasierung, zweites kolorektales oder nicht kolorektales Karzinom und ein Tod jeder Ursache werden als Ereignis betrachtet
    c) Gesamtüberleben bei ctDNAneg Patienten, die in “Nachsorge”
    randomisiert sind (Rate der lebenden Patienten 5 Jahre nachder Randomisation nach der Kaplan-Meier Schätzung mit 95% Konfidenzintervall)
    d) Krankheitsfreies und Gesamtüberleben von ctDNApos vs. ctDNAneg Patienten (gemessen von der Randomisation bis zu einem Event als Intention to-Treat Analyse, mittels stratifiziertem Log-rank Test). Jedes Rezidiv, Metastasierung, zweites kolorektales oder nicht kolorektales Karzinom und ein Tod jeder Ursache werden als Ereignis für das krankheitsfreie Überleben betrachtet. Für das Gesamtüberleben wird ein Tod jeder Ursache als Ereignis betrachtet.
    e) Ort der Metastasierung (Lymphknotenmetastasen vs. peritoneale Metastasen/Lokalrezidiv vs. andere) bei ctDNApos vs. ctDNAneg Patienten, die ein Rezidiv / Metastasen haben
    f) Häufigkeit von unerwünschten Ereignissen vom Beginn der Chemotherapie bis 30 Tage nach Chemotherapie (deskriptive Analyse für Patienten, die in „Chemotherapie“ randomisiert wurden und mindestens eine Dosis der Chemotherapie erhalten haben).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time of the final analysis
    Zum Zeitpunkt der finalen Analyse
    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 No
    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
    keine adjuvante Chemotherapie
    no adjuvant 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 concerned150
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    To evaluate the effect of the adjuvant therapy on disease free survival, a follow-up for disease free survival is necessary after the patients have completed their adjuvant therapy.
    Following the analysis disease free survival, an overall survival follow up (phone contacts only) is planned to estimate the effect on long term survival of the patients.
    Um den Einfluss der adjuvanten Therapie auf das krankheitsfreie Überleben zu untersuchen, muss eine Nachbeobachtung in Bezug auf das krankheitsfreie Überleben durchgeführt werden, wenn die Patienten die adjuvante Therapie bereits beendet haben.
    Nach der Analyse für das krankheitsfreie Überleben wird noch eine Nachbeobachtung für das Gesamtüberleben angeschlossen, um den Effekt der adjuvanten Chemotherapie auf das Langzeitüberleben einzuschätzen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 2500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2312
    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 state2546
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4412
    F.4.2.2In the whole clinical trial 4812
    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)
    If the trials ends before the patients have completed the routine follow-up for colon cancer (five years), the patients will be followed up within the clinical routine.
    Wenn die Studie beendet wird, bevor die Patienten die übliche Zeit für die Nachsorge beendet haben, erhalten die Patienten die Nachsorge im Rahmen der klinischen Routine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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