Therapy of locally advanced rectal cancer of the upper third by quality controlled total versus partial mesorectal excisio

Completed

Conditions: Rectal cancer
Cancer

Registration Number: ISRCTN35198481

Lead Sponsor: Georg-August University of Gottingen (Georg-August-Universitat Gottingen, Universitatsmedizin) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 360

Inclusion Criteria

1. Histologically confirmed advanced primary rectum carcinoma at a level 12 - 16 cm above the anocutaneous verge (as measured by rigid endoscopy), endosonographically classified as uT3-4 or uN+ carcinomas, no evidence for synchronous distant metastases
2. Patients aged 18 - 85 years, either sex
3. No preliminary treatment of rectum carcinoma

Exclusion Criteria

1. Successfully treated secondary malignoma with the exception of basal cell carcinoma of the skin and in situ cervix carcinoma, respectively, The inclusion of patients with other tumours, that have been treated successfully and have not reappeared during the last 5 years, has to be discussed with the principal investigator
2. Simultaneous therapy with other anti-cancer drugs
3. Chronic colonic diseases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival after 3 years (local and/ or distant recurrences).

Secondary Outcome Measures

Name	Time	Method
1. R0-rate of resection<br>2. Post-operative 30-day lethality<br>3. Post-operative morbidity (especially rate of anastomotic insufficiencies)<br>4. Cumulative incidence of local relapses and distant metastases<br>5. Survival after 3 and 5 years<br>6. Acute and late toxicity of the chemotherapy according to the Common Toxicity Criteria of the National Cancer Institute (NCI CTC version 2.0) <br>7. Post-operative late complications (defaecation problems, anastomotic stenoses, loss of sphincter function)<br>8. Quality of TME and PME as assessed<br>9. Quality of life according to the European Organisation for Research and Treatment of Cancer (EORTC)-Questionnaire QLQ-30 (3.0)<br><br>Assessment of safety: TME, PME, and adjuvant chemotherapy are established procedures.