A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
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).
2 weeks after completion of radiotherapy
Prajnan Das, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board