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

This study is testing if using a special guide called the PAGODA algorithm can help prevent unplanned delays during chemotherapy for certain gastrointestinal (GI) cancers. These cancers include those of the ampulla of Vater, appendix, colon, and esophagus, as well as cancers of unknown origin with a GI profile. You would receive standard chemotherapy with Oxaliplatin, Folinic Acid, and Fluorouracil. The study wants to see if using the PAGODA algorithm to decide when to delay or change chemotherapy doses leads to fewer unplanned delays compared to usual care. To join, you must be at least 18 years old and have a confirmed GI cancer that would normally be treated with FOLFOX-based chemotherapy. The study is currently unclear about its recruitment status and plans to enroll 420 participants.

Study design: This is an interventional study where participants are randomly assigned to one of two groups. One group receives chemotherapy delays and dose changes based on the PAGODA algorithm, while the other receives usual care.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary goal is to measure unplanned chemotherapy delays from cycle 2 to 7 (with an undelayed cycle length of 14 days).

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

Recruiting

NAAges 18+InterventionalHealth services

Alliance for Clinical Trials in Oncology

~420 participants

Updated 2026-08-05 on ClinicalTrials.gov

What's tested:PAGODA algorithmOxaliplatinFolinic AcidFluorouracil

At a glance

Recruiting sites

357 of 363 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of unplanned chemotherapy delays

Measured over From cycle 2 to 7 (Undelayed cycle length= 14 days)

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

Where it's being run

363 sites across 39 states

Michigan57

Minnesota47

Illinois35

Wisconsin32

Missouri26

Iowa18

Kansas13

California11

Study leadership

Gabriel A. Brooks, MD, MPH · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

Who to contact

Lilli Johnson

[email protected]

(773) 702-9171

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\* 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

What this trial measures

Incidence of unplanned chemotherapy delaysFrom cycle 2 to 7 (Undelayed cycle length= 14 days)
Will employ a generalized linear mixed effects model with logit link function, with a random patient effect to account for clustering of cycles within patients. Will test if additional random effects are needed (e.g., provider or clinic level). Statistical significance will be assessed at the 5% level. Delays will be assessed over cycles 2 through 7, and a delay will be defined as an interval of \> 18 days since day 1 of the previous cycle. An unplanned delay will be defined as any delay that was not prospectively planned by day 3 of the previous cycle.

Trialytics