Status:
TERMINATED
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 redu...
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01148056
Start Date
March 1 2010
End Date
April 1 2014
Last Update
February 15 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114