Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
This study will investigate short course radiation therapy using IMRT as an alternative to standard chemo radiation because prior studies have shown that this method of treatment will potentially reduce some fo the side effects of standard treatment, improve quality of life, and help to control the growth of rectal cancer cells. IMRT is a type of radiation that uses computer-generated images to match radiation to the size and shape of the tumor. Since the intensity of each radiation beam can be controlled, the radiation dose can wrap around normal tissue which allows the study doctor to deliver a higher dose of radiation to the tumor with less damage to nearby healthy tissue. The purpose of this research study is to see what impact this treatment will have on quality of life, as well as to see if there are any late side effects that come about after the participant has completed the treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Short Course Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer: An Analysis of Quality of Life and Biomarkers of Response|
- Bowel Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.
- Pelvic Control Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the pelvic control rate of patients after short course radiation therapy and surgery.
- Surgical Complication Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the surgical complication rate in patients who received preoperative radiation therapy.
- Tissue Microarray [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine changes in the tumor induced by radiation as assessed by tissue microarray.
- Quantity of Circulating Tumor Cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.
- Accuracy [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the accuracy of advanced MRI imaging and PET/CT in predicting nodal stage.
|Study Start Date:||March 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Short course IMRT
Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Radiation: Intensity Modulated Radiation Therapy
Radiation therapy once a day for 5 days
Other Name: IMRT
- Radiation treatment to the rectum will be given once a day, for 5 days. Each radiation treatment will take about 20-30 minutes.
- The following procedures will be performed on day 1 of radiation treatment: physical examination, blood tests and quality of life questionnaire.
- During radiation treatment a physical examination will be performed once during the 5 days of radiation treatment. A Quality of Life Questionnaire will be administered on the last day of radiation treatment.
- Surgery will be performed within 3-14 days after the last day of radiation treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148056
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hosptial|