Proton Therapy With Capecitabine for Rectal Cancer
The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial.
The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD.
- To evaluate local tumor response in patients treated with the above regimen.
- To evaluate the relapse-free and overall survival in patients treated with the above regimen.
- To evaluate proton dosimetry in patients receiving this treatment.
- To evaluate quality of life in patients receiving this therapy.
Procedure: Proton Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer|
- Maximum Tolerated Dose (MTD) [ Time Frame: 2 weeks after completion of radiotherapy ] [ Designated as safety issue: Yes ]MTD of a fixed dose of capecitabine (825 mg/m²) and 3 escalating doses of proton radiotherapy (5400, 5940, 6300 cobalt centiGray equivalent) as measured by dose-limiting toxicities using the continual reassessment method (CRM).
|Study Start Date:||July 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: Proton Therapy + Capecitabine
Capecitabine 825 mg/m^2 by mouth twice daily on Proton Therapy (radiation) days.
Procedure: Proton Therapy
Radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all).
Other Names:Drug: Capecitabine
825 mg/m^2 by mouth (PO) twice daily on days receive radiation.
Other Name: Xeloda
Proton beams can be used to deliver a high dose of radiation to the treatment area while sparing surrounding normal tissues. Capecitabine is a drug that interferes with the growth of cancer cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Urine will be collected for routine tests. Chest x-rays and computed tomography (CT) scans of the abdomen (stomach area) and pelvis will be done. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all). You will take the chemotherapy drug, capecitabine, by mouth 2 times a day, at morning and night, on each of the days that you receive radiation therapy. These pills will not be taken on Saturday or Sunday. These pills should be taken within 30 minutes of eating and with a full glass of water.
During the study, every week you will have a physical exam and blood (about 2 teaspoons) will be drawn to check for side effects from chemotherapy and radiation therapy. You will be asked about any side effects you are experiencing.
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment. Those with tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after completion of treatment, as they would for the standard of care for their disease.
You will be taken off study if the disease gets worse or intolerable side effects occur.
Two (2) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam. Blood (about 2 teaspoons) will be collected for routine tests. You will be asked about any side effects you are experiencing. Six (6) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam, chest x-ray, and CT scan of your abdomen and pelvis. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will be asked about any side effects you are experiencing.
After finishing treatment, you will have a follow-up visit every 3 months for the first 2 years, and every 6 months after that. At each visit, you will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and CT scan of the abdomen and pelvis. You will be asked about any side effects you are experiencing.
One (1) year after you finish treatment, you will also have a colonoscopy or sigmoidoscopy. You will receive a separate consent for these procedures.
After participation in the study is over, you will have follow-up evaluation as needed for standard of care.
This is an investigational study. Capecitabine is FDA approved for treating colon cancer after surgery, and for treating metastatic colorectal cancer. The use of capecitabine with proton beam therapy in this study is investigational. About 50 patients will take part in this study. All will be enrolled at M. D. Anderson.