Spots Global Cancer Trial Database for Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

Official Title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Study ID: NCT00979680

Conditions

Rectal Cancer

Interventions

High-Dose radiotherapy

Chemo-radiotherapy

Study Description

Brief Summary: This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

Detailed Description: