Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer

Inclusion Criteria

• •Histologically confirmed, locally advanced, non-metastatic primary T3 or T4 primary adenocarcinoma of the rectum
• •No evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
• •No intra-operative radiotherapy (IORT) or brachytherapy will be allowed
• •The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of anal verge by proctoscopic examination
• •Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following:
• •* CT scan plus endorectal ultrasound or
• •* MRI
• •Tumors must be defined prospectively by the surgeon as clinically resectable or not; clinically resectable tumors will be defined by the surgeon as mobile and completely resectable with negative margins based on the routine examination of the non-anesthetized patient; before pre-op treatment, the surgeon should estimate and record the type of resection anticipated: APR, LAR, or LAR/coloanal anastomosis
• •The tumor may be clinically fixed or initially not completely resectable, clinical stage T4, N0-2, M0 based on the presence of at least one of the following criteria:
• •* Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum
• •* Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation
• •* Hydronephrosis on CT scan or IVP or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate
• •* Vaginal or uterine involvement
• •ECOG performance status 0-2 and surgical evaluation confirms the patient's medical condition would tolerate the proposed surgical procedure
• •Caloric intake should be \>= 1500 kilocalories/d
• •WBC \>= 3500/uL
• •Platelets \>= 100,000/uL
• •Serum creatinine =\< 2.0 mg/dL
• •Serum bilirubin less than 2.0 mg/dL
• •Alk Phos =\< 2 x ULN
• •SGOT =\< 2 x ULN
• •CEA should be determined prior to initiation of therapy
• •Absence of clinical evidence of high-grade (lumen diameter \< 1cm) large bowel obstruction, unless diverting colostomy has been performed