Rectal cancer
Conditions
Interventions
The study treatment consists of adjuvant chemo-radiotherapy (25x1.8 Gy) limited
to the mesorectum with concurrent capecitabine (825 mg/m2). To monitor the risk
of recurrence, there will be additiona
Sponsors
Amsterdam UMC, locatie VUmc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD/endoscopic intramuscular dissection or polypectomy) of an early rectal cancer without carcinoma in the resection plane. 2. Patients without 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, tumour budding, 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 tumour budding or 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.
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 that interferes with the outcomes 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is local recurrence after 3 year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary mortality, morbidity, stoma rate, long term interventions, functional outcomes, health related quality of life (HRQoL) and costs. | — |
Countries
Netherlands
Outcome results
None listed