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:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01148056
First received: June 18, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Radiation: Intensity Modulated Radiation Therapy
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: March 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148056

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hosptial
  More Information

No publications provided

Responsible Party: Theodore Sunki Hong, Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01148056     History of Changes
Other Study ID Numbers: 09-157
Study First Received: June 18, 2010
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
IMRT
radiation therapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014