Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
|ClinicalTrials.gov Identifier: NCT01148056|
Recruitment Status : Terminated (The study was closed to enrollment due to slow accrual.)
First Posted : June 22, 2010
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Intensity Modulated Radiation Therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2010|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Experimental: Short course IMRT
Patients will receive short course IMRT (Intensity Modulated Radiation Therapy) 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
- Bowel Quality of Life [ Time Frame: 2 years ]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 ]To determine the pelvic control rate of patients after short course radiation therapy and surgery.
- Surgical Complication Rate [ Time Frame: 2 years ]To determine the surgical complication rate in patients who received preoperative radiation therapy.
- Tissue Microarray [ Time Frame: 2 years ]To determine changes in the tumor induced by radiation as assessed by tissue microarray.
- Quantity of Circulating Tumor Cells [ Time Frame: 2 years ]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 ]To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148056
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hosptial|