Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma
Condition: Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma; Rectal Neoplasms
Intervention: FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}; Low dose fractionated radiation therapy (LDFRT)
Intervention description: see arm description; see arm description
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pelvic Radiotherapy; Rectal Adenocarcinoma

Summary:

      The purpose of this study is to assess the effects, both good and bad, of adding very low
      dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to
      surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over
      approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each
      cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the
      first two days of each cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥ 18 years old at diagnosis.

          2. ECOG Performance Status 0, 1, or 2.

          3. Biopsy-proven diagnosis of rectal adenocarcinoma.

          4. Radiographically measurable or clinically evaluable disease by CT scan of
             chest/abdomen/pelvis with and without contrast ≤ 28 days prior to registration.

          5. Clinical AJCC 7th edition stage T2N1M0, T3N0M0 or T3N1M0 based on physical
             examination, CT scan chest/abdomen/pelvis, and pelvic MRI or endorectal ultrasound.

          6. Preoperative proctoscopy confirming tumor extent as no less than 5 cm and no greater
             than 12 cm from the anal verge.

          7. Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist ≤ 28
             days prior to registration.

          8. Confirmation by a surgeon that the patient is able to undergo a low anterior resection
             with total mesorectal excision ≤ 28 days prior to registration.

          9. In the absence of a being treated on a clinical trial, the patient would be
             recommended to receive neoadjuvant chemoradiation followed by curative intent surgery.

         10. The following laboratory values obtained ≤ 28 days prior to registration:

               -  Absolute neutrophil count (ANC) ≥ 1500/mm3.

               -  Platelet count ≥ 100,000/mm3.

               -  Hemoglobin > 8.0 g/dL. May transfuse to meet eligibility.

               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN).

               -  SGOT (AST) ≤ 3 x ULN.

               -  SGPT (ALT) ≤ 3 x ULN.

               -  Creatinine ≤ 1.5 x ULN.

         11. Negative pregnancy test (B-HCG) within 7 days prior to registration for women of
             childbearing potential.

         12. Did the patient provide study-specific informed consent prior to study entry?

         13. Willingness to return to the enrolling medical site for all study assessments.

        Exclusion Criteria:

          1. Clinical T4 tumor.

          2. Primary surgeon indicates the need for an abdominal perineal resection (APR) at
             baseline.

          3. Previous pelvic RT.

          4. Autoimmune disease such as scleroderma, lupus, or inflammatory bowel disease.

          5. Tumor < 3 mm from the mesorectal fascia as seen on MRI or endorectal ultrasound.

          6. Tumor-induced symptomatic bowel obstruction.

          7. Chemotherapy (including hormonal therapy) within the past 5 years from date of
             registration.

          8. Other invasive malignancies within past 5 years from date of registration.

          9. Pregnant or nursing women.

         10. Men or women of childbearing potential who are unwilling to employ adequate
             contraception.

         11. Other co-morbid conditions that, based on the judgment of the physicians obtaining
             informed consent, would make the patient inappropriate for this study.

         12. Any conditions that would preclude a patient from completing all study assessments.