Find A Research Study

This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive fluorouracil IV continuously and undergo radiotherapy once daily 5 days a week for 5-6 weeks. Arm II: Patients receive fluorouracil and undergo radiotherapy as in arm I. Patients also receive oxaliplatin IV over 1 hour once weekly for 5 weeks. Arm III: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5-6 weeks. Arm IV: Patients receive capecitabine and undergo radiotherapy as in arm III. Patients also receive oxaliplatin as in arm II. Within 6-8 weeks after the completion of chemoradiotherapy, patients with responding or stable disease undergo surgery. Patients with progressive disease are treated at the discretion of the investigator and continue to be followed.

Diagnosis of adenocarcinoma of the rectum

Diagnosis obtained within the past 42 days by a biopsy technique which leaves the major portion of the tumor intact
Stage II (T_3-4, N_0 [N_0is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T_1-4, N_1-2 [with the definition of a clinically positive lymph node being any node ? 1.0 cm]

Clinically staged by transrectal ultrasound or MRI with endocoil or endoluminal ultrasound AND CT scan, MRI, or combined PET/CT scan
Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
Distal border of the tumor must be located < 12 cm from the anal verge
Tumor amenable to curative resection* NOTE: *Curative resection can include pelvic exenteration
No history of invasive rectal malignancy, regardless of disease-free interval
No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma)
No synchronous colon cancer
No clear indication of involvement of the pelvic side walls by imaging
No evidence of metastatic disease

Study Summary:

Detailed Study Description:

Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Rectal Cancer
Intervention Type: drug and radiation therapy
Intervention Name: capecitabine, fluorouracil, oxaliplatin and radiotherapy
Gender: Male and Female
Age group: Interventional
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)