Title: A 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 (PROSPECT)1

Principal Investigator: Deborah Schrag, MD, Dana-Farber Cancer Institute

Description: For this open-label phase 2/3 study (ClinicalTrials.gov Identifier: NCT01515787), investigators are comparing the efficacy of 5-FU or capecitabine plus radiation (5FUCMT) with that of 5-FU, oxaliplatin, plus leucovorin (FOLFOX) in patients with locally advanced rectal cancer.

Patients in the FOLFOX arm will receive FOLFOX once every 2 weeks for 6 cycles and then undergo MRI scans or endorectal ultrasound to determine response to treatment. If the tumor size decreases by at least 20%, patients will proceed to surgery; if not, patients will receive 5FUCMT.

Post-surgery, if tumor borders are normal, patients will receive 6 additional cycles of FOLFOX. If borders are not normal, patients will undergo 5FUCMT for 5.5 weeks and then 4 cycles of FOLFOX or another chemotherapy regimen.

Patients in the 5FUCMT arm will undergo treatment for 5.5 weeks and proceed directly to surgery. They will then will receive adjuvant FOLFOX chemotherapy every 2 weeks for 8 cycles.

The estimated study enrollment is 1120 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01515787.

Status: Open and recruiting patients as of February 22, 2018.

This study is sponsored by Alliance for Clinical Trials in Oncology in collaboration with the National Cancer Institute.

Reference

  1. ClinicalTrials.gov. PROSPECT: chemotherapy alone or chemotherapy plus radiation therapy in treating patients with locally advanced rectal cancer undergoing surgery. NCT01515787. https://clinicaltrials.gov/ct2/show/NCT01515787. Accessed February 22, 2018.