Short radiation course for rectal cancer aims to ease side effects
NCT ID NCT01148056
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a short course of targeted radiation (IMRT) given over one week before surgery for rectal cancer. The goal was to see if this approach could reduce side effects like bowel problems and improve quality of life compared to standard longer treatments. Only 2 people took part before the study was stopped early, so results are very limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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2 people
The number who actually took part.
- Start date
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Mar 2010
- Finished
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Apr 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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