Clinical trial NCT01148056: Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: IMRT
radiation therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
First posted: 2010-06-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bowel Quality of Life
timeFrame: 2 years
Secondary outcomes:
measure: Pelvic Control Rate
timeFrame: 2 years
measure: Surgical Complication Rate
timeFrame: 2 years
measure: Tissue Microarray
timeFrame: 2 years
measure: Quantity of Circulating Tumor Cells
timeFrame: 2 years
measure: Accuracy
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hosptial
name: Theodore S. Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: