Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum
Condition: Cancer of Rectum; Cancer of the Rectum; Neoplasm, Rectum; Rectal Cancer; Rectum Cancer; Rectum Neoplasms; Adenocarcinoma of the Rectum
MeSH terms: Neoplasms; Adenocarcinoma; Rectal Neoplasms
Intervention: Radiation; Oxaliplatin; Leucovorin; Fluorouracil
Intervention MeSH terms: Leucovorin; Tetrahydrofolates; Formyltetrahydrofolates; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to look at how tumors responds to a short course of
      radiation (5 days) followed by 8 cycles of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the
             rectum; staging must also be based on multidisciplinary evaluation including MRI
             and/or endorectal ultrasound

          -  Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a

          -  ECOG performance status 0-2

          -  At least 18 years of age

          -  Adequate bone marrow function defined as:

               -  ANC > 1,500 cells/mm3

               -  Hgb > 8 g/dl

               -  platelets >100,000 cells/mm3

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control, abstinence) prior to study entry and for
             the duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she must inform her treating physician
             immediately.

          -  Able to understand and willing to sign an IRB-approved written informed consent
             document.

        Exclusion Criteria:

          -  No clinically detectable (MR, endoscopy or DRE) tumor present

          -  Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.

          -  Any evidence of disease from another malignancy or history of other malignancy ≤ 3
             years previous with the exception of basal cell or squamous cell carcinoma of the skin
             which were treated with local resection only or carcinoma in situ of the cervix).
             Patients with history of prostate cancer treated without radiotherapy and no evidence
             of disease are eligible.

          -  Currently receiving any investigational agents.

          -  A history of allergic reaction attributed to compounds of similar chemical or biologic
             composition to 5FU, oxaliplatin, or leucovorin.

          -  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 and/or breastfeeding. Women of childbearing potential must have a negative
             serum pregnancy test within 14 days of study entry.

          -  Known HIV-positivity and on combination antiretroviral therapy because of the
             potential for pharmacokinetic interactions with the study drugs. In addition, these
             patients are at increased risk of lethal infections when treated with
             marrow-suppressive therapy. Appropriate studies will be undertaken in patients
             receiving combination antiretroviral therapy when indicated.