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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

Phase 2
18 Years
Not Enrolling
Rectal Cancer

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Trial Information

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Bowel Quality of Life

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Theodore S. Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hosptial


United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Rectal Cancer
  • IMRT
  • radiation therapy
  • Rectal Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617