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

Primary Purpose

Rectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensity Modulated Radiation Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring IMRT, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Short course IMRT

Arm Description

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

Outcomes

Primary Outcome Measures

Bowel Quality of Life
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.

Secondary Outcome Measures

Pelvic Control Rate
To determine the pelvic control rate of patients after short course radiation therapy and surgery.
Surgical Complication Rate
To determine the surgical complication rate in patients who received preoperative radiation therapy.
Tissue Microarray
To determine changes in the tumor induced by radiation as assessed by tissue microarray.
Quantity of Circulating Tumor Cells
To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.
Accuracy
To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.

Full Information

First Posted
June 18, 2010
Last Updated
December 22, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01148056
Brief Title
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was closed to enrollment due to slow accrual.
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
IMRT, radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short course IMRT
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Other Intervention Name(s)
IMRT
Intervention Description
Radiation therapy once a day for 5 days
Primary Outcome Measure Information:
Title
Bowel Quality of Life
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pelvic Control Rate
Description
To determine the pelvic control rate of patients after short course radiation therapy and surgery.
Time Frame
2 years
Title
Surgical Complication Rate
Description
To determine the surgical complication rate in patients who received preoperative radiation therapy.
Time Frame
2 years
Title
Tissue Microarray
Description
To determine changes in the tumor induced by radiation as assessed by tissue microarray.
Time Frame
2 years
Title
Quantity of Circulating Tumor Cells
Description
To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.
Time Frame
2 years
Title
Accuracy
Description
To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore S. Hong, MD
Organizational Affiliation
Massachusetts General Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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