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Randomized Study Comparing PAGODA Algorithm and Physician Discretion for Adjusting FOLFOX Chemotherapy to Reduce Unplanned Delays in Gastrointestinal Cancers
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-08-05
420
Participants Needed
363
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether using the PAGODA algorithm to guide chemotherapy dosing can reduce unplanned delays during chemotherapy for cancers in the gastrointestinal system. This study compares the PAGODA algorithm against usual care in patients receiving FOLFOX chemotherapy. The trial aims to assess the effect on treatment scheduling, healthcare contact days, severity of neutropenia, and chemotherapy dose intensity. Participants are randomly assigned to one of two groups. One group receives chemotherapy dose adjustments and delays based on the PAGODA algorithm followed by clinician decision during cycles 2 to 7 of standard FOLFOX chemotherapy. The other group receives dose modifications and delays at the treating clinicians discretion during the same chemotherapy cycles. Treatments include intravenous oxaliplatin, folinic acid, and fluorouracil. During the study, participants will be monitored for unplanned chemotherapy delays from cycle 2 through cycle 7, with each cycle lasting 14 days. Researchers will also track health care contact days over 120 days, moderate-to-severe neutropenia, and relative dose intensity of key chemotherapy drugs. The study involves randomized assignment and careful evaluation of treatment timing and dosing effects in patients receiving chemotherapy for gastrointestinal cancers.
CONDITIONS
Brief Title
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Research Team
L
Lilli Johnson
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