Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00611858|
Recruitment Status : Terminated (Slow accrual)
First Posted : February 11, 2008
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: Cetuximab Drug: 5-Fluorouracil Radiation: External Beam Pelvis Radiation Therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2017|
- 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. [ Time Frame: 3 years ]
- Determine complete resection rate, local recurrence rate, distance recurrence rate, disease free survival and overall survival in this patient population with this treatment. [ Time Frame: 3 years ]
- Characterize toxicity profile of neoadjuvant therapy with cetuximab, 5-FU and radiation in this patient population. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611858
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|South Shore Hospital|
|Weymouth, Massachusetts, United States|
|United States, Tennessee|
|Vanderbilt Medical Center|
|Nashville, Tennessee, United States|
|Principal Investigator:||Jeffrey Meyerhardt, MD, MPH||Dana-Farber Cancer Institute|