PAGODA Algorithm for Gastrointestinal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the PAGODA algorithm can guide chemotherapy dosing to reduce unexpected treatment delays for people with gastrointestinal (GI) cancer. It compares two approaches: one where doctors make treatment adjustments as usual, and another where the PAGODA algorithm guides adjustments. Individuals diagnosed with GI cancer and undergoing FOLFOX chemotherapy (a combination of Fluorouracil and Oxaliplatin), without prior systemic treatment for this cancer type, might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment strategies.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your current medications might interact with the trial requirements.
What prior data suggests that the PAGODA algorithm is safe for guiding chemotherapy dosing?
Research has shown that the PAGODA algorithm is generally safe. Previous studies found that using this algorithm in chemotherapy rarely causes treatment delays due to low blood cell counts. This indicates that the algorithm helps adjust doses for better patient tolerance.
The chemotherapy drugs used in this study, fluorouracil and oxaliplatin, are standard treatments for gastrointestinal cancers. These drugs have been used in many patients and have known safety profiles. While patients often tolerate these drugs, they can still cause side effects like nausea or fatigue, as with all chemotherapy. However, the algorithm aims to manage doses to reduce these issues.12345Why are researchers excited about this trial?
Researchers are excited about the PAGODA Algorithm trial because it offers a new way to personalize chemotherapy for gastrointestinal cancer. Unlike the standard approach, which relies heavily on the physician's discretion for determining chemotherapy schedules and doses, the PAGODA Algorithm uses a data-driven method to guide these decisions. This could lead to more precise and effective treatment plans, potentially improving patient outcomes by minimizing side effects and enhancing the effectiveness of the chemotherapy regimen.
What evidence suggests that the PAGODA algorithm is effective for reducing chemotherapy delays in gastrointestinal cancer?
This trial compares two approaches for managing chemotherapy in patients with gastrointestinal cancer. In Arm A, clinicians will decide on chemotherapy delays and dose modifications. In Arm B, chemotherapy adjustments will follow the PAGODA algorithm, with subsequent clinician input. Studies have shown that the PAGODA algorithm helps doctors adjust chemotherapy doses to prevent treatment delays. Research indicates that using PAGODA can significantly reduce unexpected delays caused by side effects like a drop in blood cells. Specifically, one study linked this approach to fewer delays related to these side effects, suggesting it smooths the chemotherapy process. The algorithm aims to make treatment more consistent and reduce disruptions, improving overall care for patients with gastrointestinal cancer.12346
Who Is on the Research Team?
Gabriel A. Brooks, MD, MPH
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for adults with confirmed gastrointestinal cancers (like colon, stomach, or esophagus) who are starting FOLFOX chemotherapy and meet certain blood and organ function levels. People can't join if they've had prior chemo for GI cancer (except one cycle), have severe drug allergies, specific heart conditions, or DPD deficiency.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FOLFOX chemotherapy with dose modifications based on either physician discretion or the PAGODA algorithm during cycles 2-7
Follow-up
Participants are monitored for safety and effectiveness, including assessment of neutropenia and chemotherapy dose intensity
Extended Follow-up
Participants are monitored for time toxicity and other outcomes up to 120 days after registration
What Are the Treatments Tested in This Trial?
Interventions
- Fluorouracil
- Oxaliplatin
- PAGODA algorithm
Trial Overview
The study compares using the PAGODA algorithm to adjust chemotherapy doses versus usual care in patients receiving FOLFOX-based treatment. The goal is to see if the algorithm can help prevent unplanned delays in treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
allianceforclinicaltrialsinoncology.org
allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FNews-A232402CD-BrooksAlliance E-News
If PAGODA proves successful, it could change how we manage chemotherapy for gastrointestinal cancers—making care more consistent and less ...
2.
honcology.com
honcology.com/blog/recent-clinical-trial-highlights-in-gastrointestinal-cancer-treatmentsRecent Clinical Trial Highlights in Gastrointestinal Cancer ...
... PAGODA proactive dose modification algorithm. It compares outcomes such as treatment adherence, delays, and clinical results to determine ...
Studying the PAGODA Algorithm for Chemotherapy Dose ...
This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for ...
4.
news-medical.net
news-medical.net/news/20260112/Alliance-trial-tests-proactive-chemotherapy-dose-adjustments-for-GI-cancers.aspxAlliance trial tests proactive chemotherapy dose ...
o PAGODA approach: Doctors follow the algorithm to guide dose changes. Both groups receive the same chemotherapy drugs commonly used for GI ...
Alliance Clinical Trials Advancing GI Cancer Care
PAGODA (Proactive Graduated Dose Modification Algorithm) is designed to help clinicians proactively adjust chemotherapy dosing in order to ...
Evaluating FDA-Approved GI Cancer Drugs
Conclusion: Expedited approvals have improved drug access in GI oncology, but modest benefits highlight the need to balance speed with outcomes ...
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