An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma
Patients will all receive the combined treatment of 3-D external radiation therapy plus
Xeloda®. External Radiation Therapy to the pelvis, lower abdomen and rectal area will be
given once a day, five days a week, Monday through Friday, for about five to six weeks using
three dimensional techniques.
Xeloda® (oral chemotherapy) is a pill taken by mouth. This medication will be taken during
the course of radiation therapy on days that radiation treatments are given. Xeloda pills
will be taken twice daily beginning with the first day of radiation therapy treatments and
ending on the last day of radiation therapy treatment.
The following tests and procedures are part of regular medical treatment (standard care) for
the disease and are also required for this study:
- physical examinations, sometimes including a digital rectal exam
- blood tests including a (blood) pregnancy test will be done before starting treatment
if the patient is a woman able to have children.
- ECG (heart tracing)
- chest X-ray
- ultrasound, which produces pictures of the rectal area using sound waves· CT scan of
the pelvis and abdomen
Some people may need surgery, others may require more chemotherapy, and others may require
no additional treatment depending on how their tumor responded to the Xeloda® and radiation
Patients will also be asked to complete two questionnaires about their fatigue, general
quality of life, and bowel functioning.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).
Ismail Kazem, MD
James A. Haley Veterans Administration Hospital
United States: Federal Government
|James A. Haley Veterans Administration Hospital||Tampa, Florida 33612|