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RECRUITING

NCT07283939

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2026-02-13

Completion Date

2030-05-02

Last Updated

2026-04-07

Healthy Volunteers

Yes

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

Interventions

OTHER

PAGODA algorithm

use PAGODA algorithm to determine chemotherapy delays and dose modifications

DRUG

Oxaliplatin

Given IV

DRUG

Folinic Acid

Given IV

DRUG

Fluorouracil

Given IV

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

Locations (287)

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Mercy Cancer Center

Merced, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Saint Anthony North Hospital

Westminster, Colorado, United States

Beebe Medical Center

Lewes, Delaware, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Tift Regional Medical Center

Tifton, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Saint Mary's Hospital

Centralia, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Mercy Hospital Pittsburg

Pittsburg, Kansas, United States

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Saint Joseph Hospital

Lexington, Kentucky, United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

Saint Joseph London

London, Kentucky, United States

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, United States

Christiana Care - Union Hospital

Elkton, Maryland, United States

MyMichigan Medical Center Gratiot

Alma, Michigan, United States

MyMichigan Medical Center Alpena

Alpena, Michigan, United States

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Ann Arbor, Michigan, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Henry Ford River District Hospital

East China Township, Michigan, United States

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

MyMichigan Medical Center Gladwin

Gladwin, Michigan, United States

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, United States

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, United States

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, United States

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, United States

MyMichigan Medical Center Midland

Midland, Michigan, United States

MyMichigan Medical Center Mount Pleasant

Mount Pleasant, Michigan, United States

Hope Cancer Center

Pontiac, Michigan, United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, United States

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Riverwood Healthcare Center

Aitkin, Minnesota, United States

Essentia Health - Baxter Clinic

Baxter, Minnesota, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Minnesota Oncology Hematology PA-Chaska

Chaska, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Minnesota Oncology - Coon Rapids

Coon Rapids, Minnesota, United States

Essentia Health - Saint Joseph's Crosslake Clinic

Crosslake, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Miller-Dwan Hospital

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Minnesota Oncology - Edina

Edina, Minnesota, United States

Essentia Health - Ely Clinic

Ely, Minnesota, United States

Essentia Health - Fosston

Fosston, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Essentia Health - International Falls Clinic

International Falls, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology - Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Essentia Health - Moose Lake Clinic

Moose Lake, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Essentia Health - Saint Joseph's Pequot Lakes Clinic

Pequot Lakes, Minnesota, United States

Essentia Health - Saint Joseph's Pine River Clinic

Pine River, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Essentia Health - Saint Joseph's Staples Clinic

Staples, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Sanford Cancer Center Worthington

Worthington, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Cox Cancer Center Branson

Branson, Missouri, United States

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Mercy Infusion Center - Chippewa

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Mercy Hospital Washington

Washington, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Hi-Line Sletten Cancer Center

Havre, Montana, United States

Benefis Helena Specialty Center

Helena, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

CHI Health Good Samaritan

Kearney, Nebraska, United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Creighton University Medical Center

Omaha, Nebraska, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Essentia Health Cancer Center-South University Clinic