Simply Capecitabine in rectal cancer after irradiation plus total mesorectal excision (TME)
- Conditions
- Rectal cancer, tumourCancerMalignant neoplasm of rectum
- Registration Number
- ISRCTN36266738
- Lead Sponsor
- Dutch Colorectal Cancer Group (DCCG), University Medical Centre St Radboud (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 840
1. Rectal adenocarcinoma confirmed by histological examination of the biopsy specimen, located below the level of S1/S2 on a barium enema, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan, or located within 15 cm of the anal verge, measured during withdrawal of the flexible scope
2. Preoperative short term hypofractioned radiotherapy (5 x 5 Gy)
3. TME-surgery performed
4. TNM-stage II (T3-T4, N0) or III (any T, N+) as defined by postoperative examination of the resected specimen
5. Start of chemotherapy treatment is possible within 6 weeks after surgery
6. WHO performance score =/< 2
7. Patient is considered to be mentally and physically fit for chemotherapy as judged by the medical oncologist
8. Age >/= 18 years
9. Written informed consent
10. Adequate potential for follow-up
1. Evidence of macroscopic residual disease (R2)
2. T1 or T2 tumour with the presence of micrometastasis without the presence of macrometastasis
3. Contraindications to chemotherapy, including adequate blood counts (measured after recovery from surgery):
3.1. White blood count >/= 4.0 x 10^9/l
3.2. Platelet count >/= 100 x 10^9/l
3.3. Clinically acceptable haemoglobin levels
3.4. Creatinine levels indicating renal clearance of >/= 60 ml/min
3.5. Bilirubin <25 µmol/l
4. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn?s disease or active ulcerative colitis
5. 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 10 years.
6. Known DPD deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate in rectal cancer patients, in a randomised fashion, whether post-operative chemotherapy leads to a substantial improvement in overall survival, when standardised TME-surgery and pre-operative radiotherapy and pathology are applied.
- Secondary Outcome Measures
Name Time Method 1. To investigate in a randomised fashion whether post-operative chemotherapy leads to a substantial improvement in local and distant tumour control, when standardised TME-surgery, pre-operative radiotherapy and pathology are applied <br>2. Standardisation and quality control of TME-surgery and pathology