Rectal cancer, tumor
Conditions
Interventions
Subjects will be randomised 1:1 to receive either 24 weeks of post-operative treat-ment (8 courses) with oral capecitabine twice daily, given on days 1-14 every 21 days versus no post-operative treatm
Sponsors
Dutch Colorectal Cancer Group
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rectal adenocarcinoma confirmed by histological examination of the biopsy specimen, located below the level of S1/S2 on a barium enema, CT scan or MRI scan, or either located within 15 cm of the anal verge, measured during withdrawal of the flexible scope; 2. Preoperative short term hypofractioned radiotherapy (5x5 Gy); 3. TME-surgery performed; 4. TNM-stage II (T3-T4, N0) or III (any T, N+) as defined by postoperative examina-tion 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.
Exclusion criteria
Exclusion criteria: 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) - white blood count ≥ 4.0 x 10x9/L - platelet count ≥ 100 x 10x9/L - clinically acceptable haemoglobin levels - creatinine levels indicating renal clea- rance of ≥ 60 ml/min - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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; 2. Standardisation and quality control of TME-surgery and pathology. | — |
Contacts
Public ContactC.J.H. Velde, van de
Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600
Outcome results
None listed