Ireland
--:--IST
Recruiting Not applicable

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

NCT07283939 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2026-02-13
Last updated
2026-10-28

Condition(s) studied

Ampulla of Vater CarcinomaAppendix CarcinomaCarcinoma of Unknown Primary With Gastrointestinal ProfileColon CarcinomaEsophageal CarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaMalignant Digestive System NeoplasmRectal CarcinomaSmall Intestinal Carcinoma

Investigational drug(s) / intervention(s)

PAGODA algorithmOxaliplatin →Folinic Acid →Fluorouracil →

PAGODA algorithm: use PAGODA algorithm to determine chemotherapy delays and dose modifications

Oxaliplatin: Given IV

Folinic Acid: Given IV

Fluorouracil: Given IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 * Concomitant monoclonal antibodies are permitted during FOLFOX-based chemotherapy (e.g. anti-VEGF, anti-EGFRs, anti-PD1/PDL1, and anti-HER2) * Patients receiving concomitant therapy with irinotecan or docetaxel are not eligible * 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 * Patients with 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 * Patients with known dihydropyrimidine dehydrogenase (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

Primary outcome measure(s)

  • Incidence of unplanned chemotherapy delays — From 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.

Trial sites (368)

FacilityCityRegionStatus
Fairbanks Memorial Hospital Fairbanks Alaska Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas Recruiting
CARTI Cancer Center Little Rock Arkansas Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Mercy Cancer Center Merced California Recruiting
Mercy Cancer Center - Rocklin Rocklin California Recruiting
Mercy Cancer Center - Sacramento Sacramento California Recruiting
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California Recruiting
Mission Hope Medical Oncology - Santa Maria Santa Maria California Recruiting
Saint Joseph's Medical Center Stockton California Recruiting
Woodland Memorial Hospital Woodland California Recruiting
Penrose-Saint Francis Healthcare Colorado Springs Colorado Recruiting
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado Recruiting
Saint Francis Cancer Center Colorado Springs Colorado Recruiting
CommonSpirit Cancer Center Mercy Durango Colorado Recruiting
Mercy Medical Center Durango Colorado Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood Colorado Recruiting
Longmont United Hospital Longmont Colorado Recruiting
Saint Mary Corwin Medical Center Pueblo Colorado Recruiting
Saint Anthony North Hospital Westminster Colorado Recruiting
Beebe Medical Center Lewes Delaware Recruiting
Beebe South Coastal Health Campus Millville Delaware Recruiting
Helen F Graham Cancer Center Newark Delaware Recruiting
Medical Oncology Hematology Consultants PA Newark Delaware Recruiting
Christiana Care Health System-Christiana Hospital Newark Delaware Recruiting
Beebe Health Campus Rehoboth Beach Delaware Recruiting
Christiana Care Health System-Wilmington Hospital Wilmington Delaware Recruiting
Holy Cross Hospital Fort Lauderdale Florida Recruiting
Northside Hospital Atlanta Georgia Recruiting
Tift Regional Medical Center Tifton Georgia Recruiting
Saint Alphonsus Cancer Care Center-Boise Boise Idaho Recruiting
Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho Recruiting
Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho Recruiting
Idaho Urologic Institute-Meridian Meridian Idaho Recruiting
Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho Recruiting

+ 328 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283939 on ClinicalTrials.gov ↗ ← All trials in Mexico