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
Conditions
Interventions
Trade Name: Xeloda
Product Name: Xeloda
Product Code: SAP-10073476
Pharmaceutical Form: Tablet
Sponsors
Vrije Universiteit Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 =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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 102
Exclusion criteria
Exclusion criteria: 1. Incomplete or inconclusive resection margin with macroscopic residual tumour. 2. T1 tumour with carcinoma 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): Local recurrence rate at a three year follow-up;Timepoint(s) of evaluation of this end point: after 3 year follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: Secondary endpoints will be determined at one year, three year and five year follow-up. | — |
Countries
France, Netherlands
Contacts
Public ContactJurriaan Tuynman
Vrije Universiteit Medical Center
Outcome results
None listed