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.

Study Overview

• Status: Terminated
• Conditions: Rectal Cancer
• Intervention / Treatment: Radiation: Intensity Modulated Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Control Rate	To determine the pelvic control rate of patients after short course radiation therapy and surgery.	2 years
Surgical Complication Rate	To determine the surgical complication rate in patients who received preoperative radiation therapy.	2 years
Tissue Microarray	To determine changes in the tumor induced by radiation as assessed by tissue microarray.	2 years
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.	2 years
Accuracy	To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Brigham and Women's Hospital
• Investigators: Principal Investigator: Theodore S. Hong, MD, Massachusetts General Hosptial

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: IMRT; radiation therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 09-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO