Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
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|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|
|Actual Primary Completion Date :||April 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|