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

Active:	Yes
Cancer Type:	Appendix Cancer Colon/Rectal Cancer Esophogeal Cancer Pancreatic Cancer Small Bowel Cancer Stomach/ Gastric Cancer	NCT ID:	NCT07283939
Trial Phases:		Protocol IDs:	A232402CD (primary) A232402CD A232402CD NCI-2025-04689
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT07283939

Summary

This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care. During standard of care treatment, chemotherapy dose changes or treatment delays are typically determined by the treating physician based on factors such as a patient’s height, weight, and blood test results obtained before each treatment cycle. If certain blood counts are too low, the next cycle of chemotherapy may be delayed or adjusted. The PAGODA algorithm is a step-by-step decision-making tool designed to help health care providers determine whether chemotherapy doses should be adjusted or delayed in patients with low neutrophil or platelet counts. Researchers will compare treatment delays, dose changes, and safety outcomes between patients managed using the PAGODA algorithm and patients receiving usual care.

Objectives

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 of moderate-to-severe neutropenia (absolute neutrophil count less than 1000/mm^3) 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.

EXPLORATORY OBJECTIVES:
I. To compare the mean number of cycles per patient with granulocyte colony stimulating factor (GCSF) support in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms.
II. To compare overall survival after 2-year follow-up in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms.
IV. To compare the proportion of chemotherapy cycles with cytopenia-related unplanned delays according to assignment to the control vs intervention arms.
V. To evaluate the acceptability of the PAGODA dose modification algorithm from the perspective of oncologists and advanced practice providers.

OUTLINE: 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 standard of care (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.

After completion of study intervention, patients are followed up at 30 and 120 days and then every 12 months for 2 years following registration.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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