Phase II Study of Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
- Prior to the first dose of cetuximab, participants will undergo a sigmoidoscopy with
biopsy for research purposes as well collection of blood samples. These tests will be
repeated between days 16 and 21.
- After treatment begins, participants will undergo the following every week; history and
physical exam; vital signs; blood tests.
- On treatment weeks 1, 2 and 3: cetuximab is given once a week. On weeks 4 through 9:
cetuximab is given weekly; continuous infusion of 5-FU will begin on day 22; treatment
with radiation therapy Monday through Friday.
- It is recommended that the participant undergo surgery 4 to 8 weeks after completion of
therapy to attempt to remove the tumor.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Jeffrey Meyerhardt, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|South Shore Hospital||South Weymouth, Massachusetts 02190|
|Vanderbilt Medical Center||Nashville, Tennessee 37232-2765|