NCT07283939

Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays

PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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 less than 1000/mm3 in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. III. To compare the relative dose-intensity of bolus 5-FU, oxaliplatin, and infusional 5-FU in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms, both overall and among the subgroup of participants treated with curative intent. OUTLINE: This is an interventional study. Patients are randomized to 1 of 2 arms. ARM A: Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study. ARM B: Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.

Conditions

• Ampulla of Vater Carcinoma
• Appendix Carcinoma
• Carcinoma of Unknown Primary With Gastrointestinal Profile
• Colon Carcinoma
• Esophageal Carcinoma
• Gastric Carcinoma
• Gastroesophageal Junction Carcinoma
• Malignant Digestive System Neoplasm
• Rectal Carcinoma
• Small Intestinal Carcinoma

Interventions

Type	Name	Description
OTHER	PAGODA algorithm	use PAGODA algorithm to determine chemotherapy delays and dose modifications
DRUG	Oxaliplatin	Given IV
DRUG	Folinic Acid	Given IV
DRUG	Fluorouracil	Given IV

Timeline

• Start date: 2026-02-13
• Primary completion: 2030-05-01
• Completion: 2030-05-02
• First posted: 2025-12-16
• Last updated: 2026-04-07

Locations

287 sites across 2 countries: United States, Puerto Rico