Clinical trial · Interventional
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays
NCT07283939CI-TRIAL-00125432recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Carcinoma | Ampulla of Vater Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Appendix Carcinoma | Appendix Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma of Unknown Primary With Gastrointestinal Profile | Carcinoma of Unknown Primary with Gastrointestinal Profile | ONTOLOGY_EXACT | 0.98 |
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Carcinoma | Gastroesophageal Junction Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Digestive System Neoplasm | Malignant Digestive System Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| PAGODA algorithm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm B- PAGODA Algorithm
- description
- Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
- interventionNames
- Other: PAGODA algorithm
- Drug: Oxaliplatin
- Drug: Folinic Acid
- Drug: Fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- Arm A- Physician Discretion
- description
- Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.
- interventionNames
- Drug: Oxaliplatin
- Drug: Folinic Acid
- Drug: Fluorouracil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.