N1048: 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)
Aims: The primary aim of the study is to assure that use of pre-operative chemotherapy followed by selected use of chemotherapy with radiation is equally as effective as the standard treatment of chemotherapy with radiation pre-operatively. The second aim is to determine if the response to either treatment results in complete regression of the tumor as demonstrated at the time of surgery. Patients would possibly avoid radiation in the investigative arm of the study depending on the tumor’s response to treatment.
Diagnosis: Locally Advanced Rectal Cancer: Stages IIA- IIIB
Principal Investigator: Joseph Muldoon, MD
IRB Approval Number: EH12-468
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Meryem Saracoglu at 847.570.2935, msaracoglu@northshore.org
Open to Enrollment: No