Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Intensity Modulated Radiation Therapy
Intervention description: Radiation therapy once a day for 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMRT; radiation therapy

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.
    

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