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

Stopped early · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01148056

Run by

Massachusetts General Hospital

People needed

2

Starts

2010-03-01

Expected to finish

2014-04-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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