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Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer

This study has been terminated.
(The study was closed to enrollment due to slow accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148056
First Posted: June 22, 2010
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
June 18, 2010
June 22, 2010
December 22, 2016
February 15, 2017
February 15, 2017
March 2010
April 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01148056 on ClinicalTrials.gov Archive Site
  • 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.
  • 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/CT in predicting nodal stage.
Not Provided
Not Provided
 
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
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
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.
  • 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rectal Cancer
Radiation: Intensity Modulated Radiation Therapy
Radiation therapy once a day for 5 days
Other Name: IMRT
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
Intervention: Radiation: Intensity Modulated Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the rectum
  • T3 or N+ disease by MRI or endoscopic ultrasound. Metastatic disease is permitted, except for known brain metastases, as long as local treatment with RT and surgery is recommended.
  • Prior chemotherapy is permitted. For patients who have previously received bevacizumab, the last dose must be greater than 4 weeks prior to initiation of radiation therapy.
  • 18 years of age or older
  • Life expectancy of greater than 3 months
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1 or 2
  • Normal organ and marrow function as outlined in the protocol
  • Women of child-bearing potential and men must agree to use of adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Pelvic radiotherapy prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Participants may not be receiving any other investigational agents. Patients may not be receiving any other treatment for their rectal cancer during study participation
  • Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of known radiation sensitivity syndrome
  • History of inflammatory bowel disease
  • Active scleroderma or CREST syndrome
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01148056
09-157
Yes
Not Provided
Plan to Share IPD: No
Theodore Sunki Hong, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hosptial
Massachusetts General Hospital
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP