NCT07283939 · Alliance for Clinical Trials in Oncology
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Fairbanks, Alaska
- Phoenix, Arizona
- Fort Smith, Arkansas
- Jonesboro, Arkansas
- Little Rock, Arkansas
- Arroyo Grande, California
- Carmichael, California
- Elk Grove, California
- Merced, California
- Rocklin, California
- Sacramento, California
- San Luis Obispo, California
And 241 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations