NSABP R-04 will compare four different chemotherapy regimens in combination with radiation treatment before surgery to see which one is most effective in preventing local recurrence after surgery.
The trial will also test differences in both clinical and pathological downstaging, ability to do surgery that avoids colostomy, side effects, and quality of life both during treatment and long-term.
Patients will be randomized to five weeks of planned pelvic radiation therapy plus:
- Continuous infusion 5-FU, five days a week, during radiation therapy
- Continuous infusion 5-FU regimen plus oxaliplatin (Eloxatin®) once a week during radiation therapy.
- Oral Xeloda® (capecitabine) twice a day, five days a week during radiation therapy
- Oral Xeloda regimen plus oxaliplatin once a week during radiation therapy.
For more information or to enroll in the trial, patients with clinical stage II and III rectal cancer that have not yet begun treatment can contact a center that is conducting it. More information is available from the National Cancer Institute.
ECOG 5204 will compare adding Avastin (bevacizumab) to FOLFOX chemotherapy after surgery for rectal cancer when patients have already received chemoradiation before their surgery.
Patients with clinically staged II or III rectal cancer are eligible after their surgery. They will be randomly assigned to adjuvant chemotherapy.
- FOLFOX (oxaliplatin, continuous infusion 5-FU, leucovorin)
- FOLFOX plus Avastin® (bevacizumab)
The objective of the trial is to find out if there are differences in survival between the two groups. The study will also explore differences in side effects, local and distant recurrences, and disease-free survival.
The National Cancer Institute has more specific information about the trial along with sites where it is being conducted and how to contact them.
Patients who received their pre-surgical chemoradiation as part of NSABP R-04 are also eligible for this trial after surgery.