Chemoradiation or Brachytherapy for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Endo-HDR (if randomized to this arm); capecitabine and IMRT (if randomized to this arm); IMRT (intensity modulated radiation therapy); FOLFOX6; Surgery
Intervention description: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy; Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy; Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications; Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus An outpatient, 46 hour continuous IV infusion provided by a home IV infusion company. The 5FU is delivered by a small pump worn in a fanny pack around the waist. The home IV infusion company will arrange your disconnect at the end of the infusion.; After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Endorectal Brachytherapy Radiation Therapy; Intensity Modulated Radiation Therapy and Capecitabine

Summary:

      This research is being done to compare the effectiveness of high dose endorectal
      brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine
      in the treatment of cancer of the lowest part of the bowel (rectum).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed adenocarcinoma of the rectum

          -  Appropriate tumor staging and location

          -  Patients should be suitable candidates for surgery and chemotherapy

          -  ECOG/WHO performance status 0-1

          -  Patients must be 18 years or older

          -  No previous history of pelvic radiation

          -  Patients must have acceptable organ and marrow function

          -  Non pregnant, non-breast feeding females under active contraception

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Evidence of distant metastatic disease

          -  Evidence of sphincter invasion on MRI

          -  Prior history of radiation to the pelvis

          -  Prior malignancy except for adequately treated basal cell or squamous cell skin
             cancer, cervical carcinoma in situ, DCIS, or other cancer from which the patient has
             been disease free for at least 3 years

          -  Presence of multiple small bowel loops trapped within the immediate tumor bed (post
             hysterectomy or prostatectomy).

          -  Use of any investigational agent within the 4 weeks preceding enrollment

          -  Previous exposure to chemotherapy for rectal cancer

          -  Uncontrolled intercurrent illness including but not limited to, ongoing or active
             infections (or infections requiring systemic treatment), symptomatic congestive heart
             failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Pregnant and breastfeeding women are excluded, as well as women of child-bearing
             potential who are unwilling or unable to use an acceptable method of birth control
             (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the
             duration of the study. Should a woman become pregnant or suspect she is pregnant while
             participating in this study she should inform her treating physician immediately.

          -  Women who are not post-menopausal and have a positive urine or serum pregnancy test or
             refuse to take a pregnancy test.

          -  Contraindication for safe MRI, implants, or other conditions that interfere with
             imaging required for the study (e.g., pacemaker or non-MRI compatible hip prostheses).
             Note: Subjects with bilateral hip implants are not eligible for the study. Subjects
             with a unilateral hip implant may be eligible assuming the implant is MRI compatible
             and does not present artifact on MRI in the areas of interest.

          -  Subject is pacemaker dependent.