Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: capecitabine; oxaliplatin; neoadjuvant therapy; radiation therapy
Intervention description: Given IV; Undergo surgery; Undergo radiotherapy
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the rectum; stage I rectal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and
      oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be
      removed.

      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin
      together with radiation therapy works in treating patients who are undergoing surgery for
      stage I rectal cancer.
    

Eligibility criteria:

        -  Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2

          -  Patient must have histologically confirmed invasive adenocarcinoma of the rectum;
             Note: patients with rectal tumors suspicious for invasion also are eligible

          -  Distal border of the patient's tumor must be within 8 cm from the anal verge as
             measured on endoscopic exam

          -  Patients with tumors fixed to adjacent structures on digital exam are NOT eligible

          -  Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or
             endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4
             tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm

          -  Patients with positive perirectal nodes on ERUS examination are NOT eligible

          -  Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are
             NOT eligible

          -  Patients with the following conditions are NOT allowed on study:

               -  Metastatic disease or other primaries (patient must have had chest X-ray/computed
                  tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a
                  colonoscopy)

               -  Previously documented history of familial adenomatous polyposis

               -  Previously documented history of hereditary non-polyposis colorectal cancer
                  diagnosed clinically (Amsterdam II criteria) or by genetic testing

               -  History of inflammatory bowel disease

               -  History of prior radiation treatments to pelvis

               -  Clinically significant peripheral sensory or motor neuropathy (defined as
                  symptomatic weakness, paresthesia or sensory alteration described to be
                  interfering with function, interfering with activities of daily living, disabling
                  or life-threatening)

               -  History of any clinically significant cardiac disease (i.e., class 3-4 congestive
                  heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia,
                  and/or myocardial infarction within the last 6 months)

               -  History of uncontrolled seizures or clinically significant central nervous system
                  disorders

               -  History of psychiatric conditions or diminished mental capacity that could
                  compromise the giving of informed consent, or interfere with study compliance

               -  History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin

               -  History of difficulty or inability to take or absorb oral medications

          -  White blood cells (WBC) >= 3000/mm^3

          -  Absolute neutrophil count (ANC) > 1,500/mm^3

          -  Hemoglobin > 9.5 mg/dl

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 3 mg/dl

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0
             times institutional upper limit of normal (ULN)

          -  Alkaline phosphatase =< 2.0 times ULN

          -  Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation

          -  Patients who have experienced a prior malignancy must have received potentially
             curative therapy for that malignancy, and must be cancer-free for at least five years
             from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin
             carcinoma, or in-situ carcinomas)

          -  Patients of reproductive potential must agree to use an effective method of birth
             control when undergoing treatments with known or possible mutagenic or teratogenic
             effects; all female participants of childbearing potential must have a negative urine
             or serum pregnancy test within two weeks prior to study registration