Rectal Cancer
Conditions
Keywords
IMRT, radiation therapy
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.
Interventions
RADIATIONIntensity Modulated Radiation Therapy
Radiation therapy once a day for 5 days
Sponsors
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Short Course Intensity Modulated Radiation Therapy (IMRT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Quality of Life | 2 years | To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Control Rate | 2 years | To determine the pelvic control rate of patients after short course radiation therapy and surgery. |
| Surgical Complication Rate | 2 years | To determine the surgical complication rate in patients who received preoperative radiation therapy. |
| Tissue Microarray | 2 years | To determine changes in the tumor induced by radiation as assessed by tissue microarray. |
| Quantity of Circulating Tumor Cells | 2 years | To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients. |
| Accuracy | 2 years | To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTheodore S. Hong, MD
Massachusetts General Hosptial
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Course IMRT Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Short Course IMRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Bowel Quality of Life
To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.
Time frame: 2 years
Population: Study was terminated early due to slow accrual. Analysis was not performed.
Secondary
Accuracy
To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.
Time frame: 2 years
Population: Study was closed early due to poor accrual. Analyses not completed.
Secondary
Pelvic Control Rate
To determine the pelvic control rate of patients after short course radiation therapy and surgery.
Time frame: 2 years
Population: Study was closed early due to poor accrual. Analyses not completed.
Secondary
Quantity of Circulating Tumor Cells
To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.
Time frame: 2 years
Population: Study was closed early due to poor accrual. Analyses not completed.
Secondary
Surgical Complication Rate
To determine the surgical complication rate in patients who received preoperative radiation therapy.
Time frame: 2 years
Population: Study was closed early due to poor accrual. Analyses not completed.
Secondary
Tissue Microarray
To determine changes in the tumor induced by radiation as assessed by tissue microarray.
Time frame: 2 years
Population: Study was closed early due to poor accrual. Analyses not completed.