NCT00527111

Pre-op Rectal ChemoRad +/- Cetuximab

A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.

Detailed description

Rectal cancer remains a significant cause of morbidity and mortality in the United States. Standard treatment for patients with locally advanced rectal cancer generally includes combined chemotherapy and radiotherapy administered either before (neoadjuvant) or after (adjuvant) definitive surgical resection. Published data from Germany has suggested advantages to a neoadjuvant strategy. Currently, the standard concurrent chemoradiotherapy regimen in the United States is pelvic irradiation administered concurrently with 5-fluorouracil (5-FU) given as a protracted venous infusion. However, local recurrence remains a problem. Recently completed randomized trials of chemoradiotherapy have demonstrated local recurrence rates between 8-17% even with currently accepted standard chemoradiotherapy and adequate surgical management. Several recent trials have explored the use of radiotherapy and cetuximab with good results. Because of the non-overlapping toxicity profiles and the potentially diverse and complimentary mechanisms of action, the combination of chemotherapy plus ERBITUX given concurrently with pelvic radiotherapy may improve on the outcomes seen with current standards for patients with locally advanced adenocarcinoma of the rectum.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab
DRUG	5-fluorouracil
RADIATION	Pelvic irradiation

Timeline

• Start date: 2007-02-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2007-09-10
• Last updated: 2016-11-03
• Results posted: 2016-11-03

Locations

41 sites across 1 country: United States