Chemoradiation OR Brachytherapy for RECTal cancer
This research is being done to compare how effective endorectal brachytherapy and external beam radiation is in treating cancer of the lowest part of the bowel (rectum). In this study, we want to find out whether giving new techniques for delivering radiation therapy (brachytherapy) before surgery can: 1) allow surgeons to successfully remove the tumor, 2) lower the risk of the tumor from returning, 3) avoid side-effects related to standard chemotherapy and external beam radiation therapy, and 4) improve the ability to complete chemotherapy following surgery. External beam radiation may increase side effects both short- and long-term by exposing normal tissue near the tumor such as the bladder, bowel and sexual organs. Instead, this study will see if using different way of delivering radiation called brachytherapy will decrease normal tissue radiation exposure and therefore decrease side effects when compared to standard of care chemotherapy and radiation. We do not know if brachytherapy will be more effective or have less toxicity when compared to standard of care chemotherapy and radiation.
- Adenocarcinoma of the rectum - T2 or T3 tumors less than or equal to 14 cm from the A-V margin (below the peritoneal reflection) or the rectosigmoid junction. - Tumor must be 1 cm above la vator on MRI - Tumors with a lumen sufficient to allow the positioning of the rectal applicator (standard probe/scope) at time of endoscopy. - Tumors of less than 4 cm thickness from the rectal mucosa documented at the time of staging images - Patients should be suitable candidates for surgery and chemotherapy - ECOG/WHO performance status 0-1 - Patients must be 18 years or older - No previous history of pelvic radiation - Patients must have acceptable organ and marrow function - Non pregnant, non-breast feeding females under active contraception - Ability to understand and willingness to sign a written informed consent document. - No evidence of distant metastatic disease - No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, DCIS, or other cancer from which the patient has been disease free for at least 3 years - No previous exposure to chemotherapy for rectal cancer - No uncontrolled intercurrent illness including but not limited to, ongoing or active infections (or infections requiring systemic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
This study will compare two treatments: 1) Endorectal brachytherapy - treats the tumor with 4 days of radiation using internal radiation directly to the tumor. 2) External beam radiation therapy - treats the tumor with external beam radiation therapy with oral chemotherapy over 5Â½ weeks. This is considered the standard of care treatment for rectal cancer.
07/30/2014 04:02 AM