Conditions: Rectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Pelvic irradiation plus 5-fluorouracil plus cetuximab arm 2: Pelvic irradiation plus 5-fluorouracil

Interventions: intervention 1: Cetuximab intervention 2: 5-fluorouracil intervention 3: Pelvic irradiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: