Full TitleA Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (Alliance #N1048)
Chemotherapy, radiation therapy, and surgery are methods used to treat rectal cancer. Radiation therapy is associated with side effects such as diarrhea and other bowel problems, so doctors want to find a way to determine which patients with locally advanced rectal cancer need radiation and which can be spared radiation without compromising the effectiveness of their treatment.
This phase II/III study is seeking to determine how well chemotherapy alone compared to chemotherapy plus radiation therapy works for treating patients with rectal cancer undergoing surgery. Patients will be randomly assigned to one of two groups:
- One group will receive FOLFOX chemotherapy (oxaliplatin, 5-fluorouracil, and leucovorin). After six cycles of treatment, patients whose tumors have shrunk by at least 20 percent will have sphincter-sparing surgery; those whose tumors shrank by less than 20 percent will have concurrent chemotherapy (with 5-fluorouracil or capecitabine) and radiation therapy for 5.5 weeks before having the surgery.
- The other group will have standard radiation therapy with 5-fluorouracil or capecitabine for 5.5 weeks, and then have sphincter-sparing surgery.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of rectal cancer that has not yet been treated.
- Patients must be candidates for sphincter-sparing surgery.
- Patients may not have had prior radiation therapy to the pelvis, nor chemotherapy in the previous five years.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.