Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Intervention: FOLFOX6; RT with concurrent chemotherapy; Surgery
Intervention description: FOLFOX6; IMRT 50.4Gy with chemotherapy
Intervention MeSH terms: Leucovorin; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neoadjuvant; chemo/radiation; rectal cancer; rectum cancer; colon cancer; colorectal cancer

Summary:

      The purpose of this study is to find out how well patients with cancer of the rectum do if
      they get all of their other treatment - chemotherapy by itself followed by chemotherapy and
      radiation together - before surgery. Patients have recently been diagnosed with rectal
      cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the
      cancer before removing it.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients must have histologically proven adenocarcinoma of the rectum with no evidence
             of distant metastases.

          -  The tumor must be clinically Stage II (T3-4 N0 with N0 being defined as all imaged
             lymph nodes are < 1.0cm) or III (T1-4 N1-2 with the definition of a clinically
             positive node being any node > 1.0cm). Stage of the tumor may be determined by CT
             scan, endorectal ultrasound or MRI.

          -  Patients must have no evidence of distant metastases including liver metastases,
             peritoneal seeding, or inguinal lymphadenopathy.

          -  Patients must not have received prior chemotherapy or pelvic radiation for rectal
             cancer, or prior pelvic radiation for any other malignancy that would prevent the
             patient from receiving the required radiation treatments for this study.

          -  Patients must have a life expectancy of 5 years, excluding their diagnosis of cancer
             (as determined by the investigator).

          -  Patients must not have an active concurrent invasive malignancy. Patients with prior
             malignancies, including invasive colon cancer, are eligible if they are deemed by
             their physician to be at low risk for recurrence. Patients with squamous or basal cell
             carcinoma of the skin, melanoma in situ, carcinoma of the cervix, or carcinoma in situ
             of the colon or rectum that have been effectively treated are eligible, even if these
             conditions were diagnosed within 5 years prior to randomization.

          -  Patients must be > 18 years of age, ECOG performance status 0-1.

          -  ANC > 1,500/µl, platelets > 100,000/µl, total bilirubin < 2.0 mg/dl or direct
             bilirubin < 1.0 mg/dl, alkaline phosphatase < 3xULN, ALT < 3xULN, creatinine <
             1.5xULN.

          -  The patient must have been evaluated by a surgeon, radiation oncologist and medical
             oncologist and all must concur that the patient is appropriate for this study.

          -  Signed informed consent; able to comply with study and/or follow- up procedures

          -  Peripheral neuropathy < grade 1

        Exclusion Criteria:

          -  Evidence of metastatic disease.

          -  Rectal cancers other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, squamous
             cell carcinoma, cloacogenic carcinoma, etc.

          -  Pregnancy or lactation at the time of proposed randomization. Eligible patients of
             reproductive potential (both sexes) must agree to use adequate contraception.

          -  Any therapy for this cancer prior to randomization.

          -  Synchronous invasive colon cancer.

          -  Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would
             preclude the patient from receiving any chemotherapy treatment option or would prevent
             required follow-up.

          -  Patients with active inflammatory bowel disease, abdominal fistula, gastrointestinal
             perforation, or intraabdominal abscess within 6 months prior to Day 0 or other serious
             medical illness which might limit the ability of the patient to receive protocol
             therapy.

          -  Prior pelvic irradiation for any indication.

          -  Known hypersensitivity to 5-fluorouracil or oxaliplatin

          -  Psychiatric or addictive disorders or other conditions that, in the opinion of the
             investigator, would preclude the patient from meeting the study requirements.