Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01148056
• Other study ID #: 09-157
• Status: Terminated
• Phase: Phase 2
• First received: June 18, 2010
• Last updated: April 10, 2014
• Start date: March 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Intensity Modulated Radiation Therapy
Radiation therapy once a day for 5 days

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 years	No
Secondary	Pelvic Control Rate	To determine the pelvic control rate of patients after short course radiation therapy and surgery.	2 years	No
Secondary	Surgical Complication Rate	To determine the surgical complication rate in patients who received preoperative radiation therapy.	2 years	No
Secondary	Tissue Microarray	To determine changes in the tumor induced by radiation as assessed by tissue microarray.	2 years	No
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.	2 years	No
Secondary	Accuracy	To determine the accuracy of advanced MRI imaging and PET/CT in predicting nodal stage.	2 years	No