NCT00297141

Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme

Detailed description

About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited. The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	chemotherapy oral use
DRUG	Oxaliplatin	chemotherapy intravenous use

Timeline

• Start date: 2004-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2006-02-28
• Last updated: 2013-12-31

Locations

8 sites across 1 country: Austria