420 Participants NeededMy employer runs this trial

PAGODA Algorithm for Gastrointestinal Cancer

Recruiting at 364 trial locations
LJ
Overseen ByLilli Johnson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alliance for Clinical Trials in Oncology
Must be taking: FOLFOX chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

GA

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

I am planning to receive at least four cycles of FOLFOX chemotherapy.
I am able to care for myself and do light activities.
ANC ≥ 1,000/mm^3
See 15 more

Exclusion Criteria

I have had systemic therapy for GI cancer, except for just one cycle of FOLFOX.
I need white blood cell growth factor with my first FOLFOX chemo due to high infection risk.
History of hypersensitivity reaction to oxaliplatin, other platinum-based drugs, fluorouracil, or leucovorin, and the excipients in their formulations
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FOLFOX chemotherapy with dose modifications based on either physician discretion or the PAGODA algorithm during cycles 2-7

12 weeks
Multiple visits for each chemotherapy cycle

Follow-up

Participants are monitored for safety and effectiveness, including assessment of neutropenia and chemotherapy dose intensity

4 weeks

Extended Follow-up

Participants are monitored for time toxicity and other outcomes up to 120 days after registration

120 days post-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

Group I: Arm B- PAGODA AlgorithmExperimental Treatment4 Interventions
Group II: Arm A- Physician DiscretionActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Alliance E-News

If PAGODA proves successful, it could change how we manage chemotherapy for gastrointestinal cancers—making care more consistent and less ...

Recent 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 ...

Alliance 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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41358945/

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 ...