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

NCT01148056 | Terminated Phase 2 Results DMC

• 1 other identifier: 09-157
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

IMRT; radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Pelvic Control Rate

  2 years

• Surgical Complication Rate

  2 years

• Tissue Microarray

  2 years

• Quantity of Circulating Tumor Cells

  2 years

• Accuracy

  2 years

Study Arms (1)

Short course IMRT

EXPERIMENTAL

Patients will receive short course IMRT (Intensity Modulated Radiation Therapy) prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after

Radiation: Intensity Modulated Radiation Therapy

Interventions

Intensity Modulated Radiation Therapy RADIATION

Radiation therapy once a day for 5 days

Also known as: IMRT

Short course IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Limitations and Caveats

Study was closed early due to poor accrual. Analyses not completed.

Results Point of Contact

• Title: Maria Kempner
• Organization: Mass General Hospital Cancer Center

mkempner@partners.org

508.533.4132

Study Officials

• Theodore S. Hong, MD

  Massachusetts General Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 15, 2017
• Results First Posted: February 15, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)