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Using the PAGODA algorithm to guide FOLFOX dose changes and reduce unplanned chemotherapy delays

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

Not applicable Interventional Alliance for Clinical Trials in Oncology · NCT07283939

This trial will test whether using the PAGODA algorithm to guide dose changes during FOLFOX chemotherapy for people with gastrointestinal cancers can reduce unplanned treatment delays.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy, radiation
Locations316 sites (Phoenix, Arizona and 315 other locations)
Trial IDNCT07283939 on ClinicalTrials.gov

What this trial studies

Patients with cancers thought to come from the gastrointestinal tract who are starting standard FOLFOX chemotherapy are randomly assigned to two groups. One group receives dose changes and delays decided by their clinician as usual, and the other group receives dose-change recommendations generated by the PAGODA algorithm to guide clinician decisions during cycles 2–7. The study will compare the proportion of chemotherapy cycles with unplanned delays as the primary outcome and will also measure health care contact days (time toxicity), rates of moderate-to-severe neutropenia, and relative dose intensity of the FOLFOX drugs. Enrollment includes patients across multiple U.S. cancer centers and requires completion of cycle 1 of FOLFOX before registration.

Who should consider this trial

Good fit: Adults with confirmed or suspected gastrointestinal cancers for whom FOLFOX is standard-of-care, who have completed cycle 1 of FOLFOX 1–8 days before enrollment and plan to receive at least four cycles, are ideal candidates.

Not a fit: Patients who are not receiving FOLFOX, who have had prior systemic therapy beyond cycle 1, or whose care requires individualized exceptions to an algorithm-based approach may not benefit from this study.

Why it matters

Potential benefit: If successful, using PAGODA could reduce unplanned chemotherapy delays and help patients receive more timely and consistent dosing.

How similar studies have performed: Algorithm-guided dose adjustments have shown promise in other chemotherapy settings, but the PAGODA algorithm itself is a newer approach that is not yet widely validated.

Eligibility criteria

Show full inclusion / exclusion 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 oxaliplatin (≥ 65 mg/m\^2) and infusional 5-FU (2400 mg/m\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician
  * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible
  * History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible
  * Age ≥ 18 years
  * ECOG performance status ≤ 2
  * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
  * Platelet count ≥ 100,000/mm\^3
  * Total bilirubin ≤ 3 x upper limit of normal (ULN)
  * AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)
  * Calc. creatinine clearance ≥ 30 mL/min
  * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required
  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
  * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration
  * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration
  * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy
  * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II
  * Patients with a known history of congenital long QT syndrome are ineligible
  * Patients with known DPD deficiency are ineligible
* \* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:

  * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study
  * The non-patient participant must be proficient in the English language
  * The non-patient participant must be age 21 years or older

Where this trial is running

Phoenix, Arizona and 315 other locations

+266 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ampulla of Vater CarcinomaAppendix CarcinomaCarcinoma of Unknown Primary With Gastrointestinal ProfileColon CarcinomaEsophageal CarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaMalignant Digestive System Neoplasm
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.