Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | March 2010 |
| Contact: | Theodore S. Hong, MD |
| Email: | tshong1@partners.org |
| Phone: | 617-724-1159 |
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.
- 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.
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
We found this trial at
2
sites
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