PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays
Alliance for Clinical Trials in Oncology
Summary
This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.
Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To compare the proportion of chemotherapy cycles with unplanned delays in patients receiving FOLFOX chemotherapy under standardized usual care (control) versus (vs) according to the PAGODA dose modification algorithm (intervention). SECONDARY OBJECTIVES: I. To compare the mean number of health care contact days (time toxicity) for patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. II. To compare the incidence moderate-to-severe neutropenia (absolute neutrophil count le…