Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma
OBJECTIVES:
Primary:
- Determine the response rate in patients with Colorectal Cancer treated with Cetuximab
and Radiation Therapy Vs Surgery before or after Radiation Therapy.
Secondary:
- To determine the progression-free survival and overall survival of patients treated
with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned
into two different Arms.
Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose
of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a
120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250
mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or
unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated
Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the
intensity of the radiation with laser accuracy.
Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer
Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and
Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated
Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the
intensity of the radiation with laser accuracy.
PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24
months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate
4 year
Yes
Ratna Grewal, MD
Study Chair
American Scitech International- eCRO
United States: Institutional Review Board
ASI-CRO0000192008
NCT00725400
February 2010
February 2014
Name | Location |
---|---|
Practicing physician in New Jersey | Englishtown, New Jersey 07726 |