Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * \* REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy) * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days) * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxalipla