5263S-12: N1048 rectal (PROSPECT study)

CTSU N1048: 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

Type of Study
Cancer (Oncology) - Rectal
Swedish Cancer Institute
Short Description
Purpose: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined-modality, neoadjuvant chemoradiation followed by curative-intent surgical resection
  • Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
  • Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)
  • Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal verge, inclusive
  • No tumor causing symptomatic bowel obstruction
  • ECOG performance status 0, 1, or 2
  • No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
  • No prior pelvic radiation

Click to view N1048 Patient FAQ

More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086