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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Fairbanks Memorial Hospital
  Fairbanks, Alaska, United States Recruiting
• Cancer Center at Saint Joseph's
  Phoenix, Arizona, United States Recruiting
• Mercy Hospital Fort Smith
  Fort Smith, Arkansas, United States Recruiting
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• CARTI Cancer Center
  Little Rock, Arkansas, United States Recruiting
• Mission Hope Medical Oncology - Arroyo Grande
  Arroyo Grande, California, United States Recruiting

+348 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Lilli Johnson
• Email: cancercontrolprotocols@allinancenctn.org
• Phone: (773) 702-9171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.