Table 1.

NSABP R-03 Trial Patient Eligibility and Ineligibility Criteria

Eligibility criteria* The patient must consent to be in the study. The informed consent form conforming to federal and institutional guidelines must be signed, witnessed, and dated prior to random assignment. Patients in whom the diagnosis of invasive rectal cancer has been obtained by incisional (surgical or endoscopic) biopsy so that the majority of the tumor has not been removed are eligible. Patients must be able to begin protocol therapy (surgery or chemotherapy) within 49 days from initial histologic diagnosis. Patients must have a life expectancy of at least 10 years, excluding their diagnosis of cancer. The tumor should be either palpable by clinical rectal examination or be accessible via a proctoscope or sigmoidoscope, and its distal border should be located no more than 15 cm from the anal verge. The tumor should be movable on clinical examination without evidence of fixation to the pelvis or to surrounding organs (vagina, prostate, bladder) beyond the limits of resection via exenteration. The patient must have no radiologic evidence of metastatic spread. The patient must have a CT scan of the abdomen and pelvis prior to random assignment. Any suspicious findings (ie, liver nodule, retroperitoneal adenopathy) will render the patient ineligible unless malignancy is ruled out by further tissue documentation (CT- or ultrasound-guided biopsy, laparoscopic biopsy, or open biopsy) prior to random assignment. Evidence by CT scan of enlarged perirectal or pelvic lymph nodes is not a condition of ineligibility unless they appear to preclude adequate surgical removal. The WBC count must be ≥ 4,000/μL and the platelet count must be ≥ 100,000/μL. There must be evidence at random assignment of adequate hepatic and renal function (bilirubin and AST or ALT; creatinine must be ≤ 1.5× the upper limit of normal for the performing laboratory). Patients with more than one synchronous rectal lesion are eligible. Patients with a performance status of 0, 1, or 2 are eligible.†

Ineligibility criteria Patients with malignant rectal tumors other than adenocarcinoma (eg, sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma). Patients who have life expectancy of < 10 years, excluding their diagnosis of cancer. Patients who demonstrate, prior to random assignment, evidence of free perforation, as manifested by free air or free fluid in the abdomen. Patients with walled-off perforations are eligible. Patients with a previous or concomitant malignancy, regardless of site, except patients with squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix that has been adequately treated. Patients who have received surgical treatment for rectal cancer, other than preliminary decompressing colostomy or diagnostic laparoscopy or laparotomy without any resection of primary tumor. Patients who have received any other therapy (radiation, chemotherapy) for rectal cancer prior to random assignment. Patients in whom rectal cancer was diagnosed by excisional biopsy (removal of polyp with adenocarcinoma, removal of villous adenoma with adenocarcinoma, etc). Patients who are unable to begin protocol therapy within 49 days from initial histologic diagnosis. Patients with a tumor whose distal border is located more than 15 cm from the anal verge. Patients whose tumor is fixed by clinical examination to surrounding structures, precluding the possibility of adequate surgical resection even with pelvic exenteration. Patients who show radiologic evidence of advanced disease (inoperable locoregional disease, or metastatic disease). Evidence of biopsy-proven retroperitoneal lymph node involvement will deem a patient ineligible. Patients who demonstrate involvement of perirectal or pelvic lymph nodes with evidence of fixation to the pelvic side wall. Patients with a performance status of 3 or 4.† Patients having nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.), which would preclude their being subjected to the treatment (surgery, chemotherapy, and radiotherapy). Patients with active inflammatory bowel disease. Patients who are pregnant at the time of random assignment. Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. Patients who have multiple primary tumors involving both the colon and rectum that would preclude them from being classified as having only rectal cancer. Patients who are found, by endoluminal ultrasonography, to have a Dukes' A lesion.

Abbreviations: NSABP R-03, National Surgical Adjuvant Breast and Bowel Project R-03; CT, computed tomography.

^*Eligible patients having histologic diagnosis by proctoscopic incisional biopsy of invasive rectal adenocarcinoma will be considered for entry in this study.

^†Performance status key: 0, normal activity; 1, symptoms but ambulatory; 2, in bed ≤ 50% of the time; 3, in bed > 50% of the time; 4, 100% bedridden.