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    Summary
    EudraCT Number:2015-000689-79
    Sponsor's Protocol Code Number:50364
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-04-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000689-79
    A.3Full title of the trial
    Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers.
    Traitement conservateur du rectum pour le cancer rectal de stade précoce : Essai multicentrique randomisé comparant la chirurgie d’exérèse rectale à la radiochimiothérapie adjuvante après excision locale d'un cancer rectal de stade précoce
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of additional surgery versus additional chemoradiotherapy after local excision for early rectal cancers.
    Traitement conservateur du rectum pour le cancer rectal de stade précoce : Essai multicentrique randomisé comparant la chirurgie d’exérèse rectale à la radiochimiothérapie adjuvante après excision locale d'un cancer rectal de stade précoce
    A.3.2Name or abbreviated title of the trial where available
    TESAR
    A.4.1Sponsor's protocol code number50364
    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 SponsorVrije Universiteit Medical Center
    B.1.3.4CountryNetherlands
    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 supportVrije Universiteit Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVrije Universiteit Medical Center
    B.5.2Functional name of contact pointJurriaan Tuynman
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444444
    B.5.6E-mailj.tuynman@vumc.nl
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Inc
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameXeloda
    D.3.2Product code SAP-10073476
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Yes
    D.3.11.13.1Other medicinal product typeChemotherapeuticum
    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
    Patients with a margin free endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer. According to current guidelines these patients require additional TME surgery after the local excision due to tumor characteristics
    E.1.1.1Medical condition in easily understood language
    Patients with an early rectal cancer that was removed by transanal excision that require addiotional surgery due to high risk tumor characteristics found in the pathology report.
    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
    The aim of this study is to determine the oncological safety of local excision followed by adjuvant chemo-radiotherapy compared to local excision followed by completion radical resection (current standard) of intermediate risk early rectal cancer
    E.2.2Secondary objectives of the trial
    Secondary objectives of this trial is to determine treatment related morbidity,functional outcome and quality of life of local excision followed by adjuvant chemo-radiotherapy compared to local excision followed by completion radical resection (current standard) of intermediate risk early rectal cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
    2. Patients with carcinoma in the resection plane or in case of unreliable resection planes (EMR/ESD) no macroscopic residual tumour confirmed by endoscopy are eligible for randomisation.
    3. Only lesions for which TME surgery is indicated can be included (If a partial mesorectal excision (PME) is indicated the patient should be excluded).
    4. Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, lymphatic and/or venous invasion.
    5. Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
    6. Complete colonoscopy, without synchronous colorectal cancer
    7. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging done within 6 weeks before randomisation. ***
    8. Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without signs of distant metastasis (cM0)
    9. Male or female, Age > 18 years.
    10. Life expectancy of at least 12 months.
    11. Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
    12. No contraindications to chemotherapy, including adequate blood counts;
    - white blood count >= 4.0 x 10 9/l
    - platelet count >=100 x 109/l
    - clinical acceptable haemoglobin levels
    - bilirubin < 35 umol/l
    - creatinine levels indicating renal clearance of >=50 ml/min
    13. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
    14. Written (signed and dated) informed consent and be capable of co-operating with protocol.
    E.4Principal exclusion criteria
    1. Incomplete or inconclusive resection margin with macroscopic residual tumour.
    2. T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without sm3, venous or lymphatic invasion.
    3. T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 3 cm
    4. Presence of metastatic disease or recurrent rectal tumour.
    5. Previous pelvic radiation
    6. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
    7. Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
    8. Pregnancy, breast-feeding or fertile women without active birth control
    9. Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (<6 months prior to randomization), myocardial infarction (<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
    10. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
    11. History of severe and unexpected reactions to fluoropyrimidine therapy
    12. Hypersensitivity to capecitabine.
    13. Patients with severe hepatic impairment.
    14. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
    15. Patients known with dihydropyrimidine dehydrogenase deficiency
    16. Any contra-indications to undergo MRI imaging.
    E.5 End points
    E.5.1Primary end point(s)
    Local recurrence rate at a three year follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 year follow-up
    E.5.2Secondary end point(s)
    - Short-term morbidity: treatment related morbidity that occurs during treatment or within 30 days after the allocated treatment. The Comprehensive Classification index (36) and the NCI CTCAE Toxicity criteria will be used to assess to degree of morbidity in both separate treatment arms.
    - Disease free and overall survival at 3 year and 5 year follow-up.
    - Stoma rate at 1, 3 and 5 year follow-up.
    - Long-term morbidity: long-term morbidity such as surgical reinterventions and readmissions related to the primary intervention will be evaluated at 1, 3 and 5 years.
    - Quality of life
    - Costs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be determined at one year, three year and five year follow-up.
    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 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
    Radical rectal resection (TME 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 concerned28
    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
    LVLS (5 year after treatment)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state302
    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)
    None
    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 Decision2019-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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