E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
T1-3 N0 M0 distal rectal tumor (below 10 cm), based on diagnostic imaging |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038038 |
E.1.2 | Term | Rectal cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found). |
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E.2.2 | Secondary objectives of the trial |
•Quality of Life Determine the faecal continence and QOL in all patients.
•Local recurrence Careful follow-up will determine the local recurrence rate of patients treated with TEM or TME surgery
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients (aged >18 years) with histological proven adenocarcinoma of the distal part of the rectum (below 10 cm) without signs of distant metastases. •T1-3 tumor without lymph nodes > 5 mm at CT, MRI and endoanal ultrasound. •ANC > 1.5 x 109/l. •Thrombocytes > 100 x 109/l. •Creatinin clearance >50ml/min (according to the Cockcroft-Gault formule) •Total serum bilirubin < 24 mmol/l or below <1.5 times the upper limit of the normal. •ASAT,ALAT: up to 5 times the upper limit. •Colonoscopy, colonography or virtual colonoscopy should exclude synchronous colorectal lesions in other parts of the colon. •ECOG performance score 0-2. •Fertile women should have adequate birthcontrol during treatment. •Mental/physical/geographical ability to undergo treatment and follow-up. •Written informed consent (Dutch language).
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E.4 | Principal exclusion criteria |
•Patients with Grade 1-2 T1 tumors (can be treated with TEM surgery without chemoradiation therapy) •Patients with circular rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra-analtumors). •Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints of soiling due to the tumor will not be an exclusion criterium). •Severe uncontrollable medical or neurological disease. •Patients with secondary prognosis determining malignancies. •Patients who have been treated with radiotherapy on the pelvis. •Use of Warfarin. •Uncontrolled active infection, compromised immune status, psychosis, or CNS disease. •Pregnant or lactating women. •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. •Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Capecitabine or patients at high risk for treatment complications. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |