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Table 1 Inclusion and exclusion criteria for the trial

From: Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management

  Inclusion Criteria Exclusion Criteria
General •Histologically confirmed diagnosis of adenocarcinoma of the rectum •Patients must have Stage II (uT3, uN0) or Stage III (T1-3, N1-3) tum or, staged by MRI, that is potentially resectable •Locally advanced rectal cancer a menable to total mesorectal excision •No evidence of distant metastases ·No prior pelvic radiation therapy •No prior chemotherapy or surgery for rectal cancer •Age >18 years •No infections requiring systemic antibiotic treatment •Karnofsky >60% or ECOG 0-2 ·ANC > 1.5 cell/mm3, Hgb>8.0 gm/ dL, PLT>150,000/mm3, total bilirubin < or equal to 1.5 x upper limit of normal, AST > or equal to upper limit of normal, ALT< or equal to three times upper limit of normal •Recurrent rectal cancer•Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical examination or pelvic MRI, is deemed tobe adherent or fixed to adjacent pelvic structures. (en bloc resection will not achieve negative margins)•Serum creatinine level greater than 1.5 times the upper limit of normal•Patients who have received prior pelvic radiotherapy•Patients with a history of any arterial thrombotic event within the past 6 months, including angina (stable or unstable), MI, or CVA•Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study•Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. •Patients with a history of thrombotic episodes, such as deep venous thrombosis, pulmonary embolus, MI, or CVA occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.• Patients receiving other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
Consent Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. MSKCC patients who do not read or understand English are eligible, but must have the consent form read to them in its entirety by an official translator, either from MSKCC or AT&T. Informed consent for non-literate or non-English speaking patients may not be obtained by using a relative or a member of the patient’s clinical team as a translator. Consortium sites must follow federal, local, and institutional regulations to ensure that non-English speaking patients are consented appropriately. n/a
Women •Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive methods. A woman of childbearing potential is defined by one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study. Women who are pregnant or breastfeeding Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, and for up to 4 weeks after the study.
Men Male subjects must also agree to use effective contraception. n/a