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

Alliance for Clinical Trials in Oncology · with National Cancer Institute (NCI) · NCT07283939

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
420
US sites recruiting
351
Study start
February 13, 2026
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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.

Being studied: PAGODA algorithm; Oxaliplatin; Folinic Acid; Fluorouracil

Conditions: 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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Fairbanks Memorial Hospital

    Fairbanks, AK 99701

    Site contact: Site Public Contact · 907-458-3043 · Veronica.Stevenson@foundationhealth.org

  • Cancer Center at Saint Joseph's

    Phoenix, AZ 85004

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Hospital Fort Smith

    Fort Smith, AR 72903

    Site contact: Site Public Contact · 800-378-9373

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, AR 72401

    Site contact: Site Public Contact · 870-936-7066 · Emily.Carvell@bmhcc.org

  • CARTI Cancer Center

    Little Rock, AR 72205

    Site contact: Site Public Contact · 501-906-4199 · Research@CARTI.com

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, CA 93420

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Cancer Center - Carmichael

    Carmichael, CA 95608

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy San Juan Medical Center

    Carmichael, CA 95608

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@commonspirit.org

  • Mercy Cancer Center - Elk Grove

    Elk Grove, CA 95758

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Cancer Center

    Merced, CA 95340

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Cancer Center - Rocklin

    Rocklin, CA 95765

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Cancer Center - Sacramento

    Sacramento, CA 95816

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, CA 93401

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, CA 93444

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Saint Joseph's Medical Center

    Stockton, CA 95204

    Site contact: Site Public Contact · 209-461-5257

  • Woodland Memorial Hospital

    Woodland, CA 95695

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Penrose-Saint Francis Healthcare

    Colorado Springs, CO 80907

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, CO 80907

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Saint Francis Cancer Center

    Colorado Springs, CO 80923

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • CommonSpirit Cancer Center Mercy

    Durango, CO 81301

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Mercy Medical Center

    Durango, CO 81301

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, CO 80228

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Longmont United Hospital

    Longmont, CO 80501

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Saint Mary Corwin Medical Center

    Pueblo, CO 81004

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Saint Anthony North Hospital

    Westminster, CO 80023

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • Beebe Medical Center

    Lewes, DE 19958

    Site contact: Site Public Contact · 302-291-6730 · research@beebehealthcare.org

  • Beebe South Coastal Health Campus

    Millville, DE 19967

    Site contact: Site Public Contact · 302-291-6730 · research@beebehealthcare.org

  • Helen F Graham Cancer Center

    Newark, DE 19713

    Site contact: Site Public Contact · 302-623-4450 · lbarone@christianacare.org

  • Medical Oncology Hematology Consultants PA

    Newark, DE 19713

    Site contact: Site Public Contact · 302-623-4450 · lbarone@christianacare.org

  • Christiana Care Health System-Christiana Hospital

    Newark, DE 19718

    Site contact: Site Public Contact · 302-623-4450 · lbarone@christianacare.org

  • Beebe Health Campus

    Rehoboth Beach, DE 19971

    Site contact: Site Public Contact · 302-291-6730 · research@beebehealthcare.org

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, DE 19801

    Site contact: Site Public Contact · 302-623-4450 · lbarone@christianacare.org

  • Holy Cross Hospital

    Fort Lauderdale, FL 33308

    Site contact: Site Public Contact · eileen.georgi@holy-cross.com

  • Northside Hospital

    Atlanta, GA 30342

    Site contact: Site Public Contact · 404-303-3355 · ClinicalTrials@northside.com

  • Tift Regional Medical Center

    Tifton, GA 31794

    Site contact: Site Public Contact · 800-648-1935

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, ID 83706

    Site contact: Site Public Contact · 734-712-3671 · stephanie.couch@stjoeshealth.org

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, ID 83605

    Site contact: Site Public Contact · 734-712-3671 · stephanie.couch@stjoeshealth.org

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, ID 83814

    Site contact: Site Public Contact · 406-969-6060 · mccinfo@mtcancer.org

  • Idaho Urologic Institute-Meridian

    Meridian, ID 83642

    Site contact: Site Public Contact · 734-712-3671 · stephanie.couch@stjoeshealth.org

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, ID 83687

    Site contact: Site Public Contact · 406-969-6060 · mccinfo@mtcancer.org

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, ID 83854

    Site contact: Site Public Contact · 406-969-6060 · mccinfo@mtcancer.org

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, ID 83864

    Site contact: Site Public Contact · 406-969-6060 · mccinfo@mtcancer.org

  • OSF Saint Anthony's Health Center

    Alton, IL 62002

    Site contact: Site Public Contact · 618-463-5623

  • Illinois CancerCare-Bloomington

    Bloomington, IL 61704

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Illinois CancerCare-Canton

    Canton, IL 61520

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Memorial Hospital of Carbondale

    Carbondale, IL 62902

    Site contact: Site Public Contact · 618-457-5200 · clinical.research@sih.net

  • SIH Cancer Institute

    Carterville, IL 62918

    Site contact: Site Public Contact · 618-985-3333 · clinical.research@sih.net

  • Illinois CancerCare-Carthage

    Carthage, IL 62321

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Centralia Oncology Clinic

    Centralia, IL 62801

    Site contact: Site Public Contact · 217-876-4762 · morganthaler.jodi@mhsil.com

  • Carle at The Riverfront

    Danville, IL 61832

    Site contact: Site Public Contact · 800-446-5532 · Research@Carle.com

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, IL 62526

    Site contact: Site Public Contact · 217-876-4762 · morganthaler.jodi@mhsil.com

  • Decatur Memorial Hospital

    Decatur, IL 62526

    Site contact: Site Public Contact · 217-876-4762 · morganthaler.jodi@mhsil.com

  • Illinois CancerCare-Dixon

    Dixon, IL 61021

    Site contact: Site Public Contact · 815-285-7800

  • Carle Physician Group-Effingham

    Effingham, IL 62401

    Site contact: Site Public Contact · 800-446-5532 · Research@carle.com

  • Crossroads Cancer Center

    Effingham, IL 62401

    Site contact: Site Public Contact · 217-876-4762 · morganthaler.jodi@mhsil.com

  • Illinois CancerCare-Eureka

    Eureka, IL 61530

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Illinois CancerCare-Galesburg

    Galesburg, IL 61401

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, IL 61443

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Illinois CancerCare-Macomb

    Macomb, IL 61455

    Site contact: Site Public Contact · 309-243-3605 · andersonj@illinoiscancercare.com

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, IL 61938

    Site contact: Site Public Contact · 800-446-5532 · Research@carle.com

+ 291 more on the official record.

Study contacts (from the official record)

  • Lilli Johnson · (773) 702-9171 · cancercontrolprotocols@allinancenctn.org
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Studying the PAGODA Algorithm for Chemotherapy Dose Changes to… (NCT07283939) | Bored Studies