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

Recruiting now · Not applicable

Conditions studied: 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

In brief

This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.

Key facts

Study ID

NCT07283939

Run by

Alliance for Clinical Trials in Oncology

People needed

420

Starts

2026-02-13

Expected to finish

2030-05-02

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• * 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

Where it is running

• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• Mercy Cancer Center — Merced, California, United States (enrolling)
• Mercy Cancer Center - Rocklin — Rocklin, California, United States (enrolling)
• Mercy Cancer Center - Sacramento — Sacramento, California, United States (enrolling)
• Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States (enrolling)
• Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States (enrolling)
• Saint Joseph's Medical Center — Stockton, California, United States (enrolling)
• Woodland Memorial Hospital — Woodland, California, United States (enrolling)
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States (enrolling)
• Saint Francis Cancer Center — Colorado Springs, Colorado, United States (enrolling)
• CommonSpirit Cancer Center Mercy — Durango, Colorado, United States (enrolling)
• Mercy Medical Center — Durango, Colorado, United States (enrolling)
• CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado, United States (enrolling)
• Longmont United Hospital — Longmont, Colorado, United States (enrolling)
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States (enrolling)
• Saint Anthony North Hospital — Westminster, Colorado, United States (enrolling)
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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