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

RecruitingHealthy volunteers welcome

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 420 · Started: Feb 13, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07283939

Locations in the U.S.

AlaskaFairbanks Memorial Hospital, Fairbanks
ArizonaCancer Center at Saint Joseph's, Phoenix
ArkansasMercy Hospital Fort Smith, Fort Smith
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro
CARTI Cancer Center, Little Rock
CaliforniaMission Hope Medical Oncology - Arroyo Grande, Arroyo Grande
Mercy Cancer Center - Carmichael, Carmichael
Mercy San Juan Medical Center, Carmichael
Mercy Cancer Center - Elk Grove, Elk Grove
Mercy Cancer Center, Merced
Mercy Cancer Center - Rocklin, Rocklin
Mercy Cancer Center - Sacramento, Sacramento
Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo
Mission Hope Medical Oncology - Santa Maria, Santa Maria
Saint Joseph's Medical Center, Stockton
Woodland Memorial Hospital, Woodland
ColoradoPenrose-Saint Francis Healthcare, Colorado Springs
Rocky Mountain Cancer Centers-Penrose, Colorado Springs
Saint Francis Cancer Center, Colorado Springs
CommonSpirit Cancer Center Mercy, Durango
Mercy Medical Center, Durango
CommonSpirit Saint Anthony Hospital Cancer Center, Lakewood
Longmont United Hospital, Longmont
Saint Mary Corwin Medical Center, Pueblo
Saint Anthony North Hospital, Westminster
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Christiana Care Health System-Wilmington Hospital, Wilmington
FloridaHoly Cross Hospital, Fort Lauderdale
GeorgiaNorthside Hospital, Atlanta
Tift Regional Medical Center, Tifton
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Idaho Urologic Institute-Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisOSF Saint Anthony's Health Center, Alton
Illinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
Memorial Hospital of Carbondale, Carbondale
SIH Cancer Institute, Carterville
Illinois CancerCare-Carthage, Carthage
Centralia Oncology Clinic, Centralia
Carle at The Riverfront, Danville
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Carle Physician Group-Effingham, Effingham
Crossroads Cancer Center, Effingham
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Illinois CancerCare-Kewanee Clinic, Kewanee
Illinois CancerCare-Macomb, Macomb
Carle Physician Group-Mattoon/Charleston, Mattoon
SSM Health Good Samaritan, Mount Vernon
Carle BroMenn Medical Center, Normal
Carle Cancer Institute Normal, Normal
Cancer Care Center of O'Fallon, O'Fallon
HSHS Saint Elizabeth's Hospital, O'Fallon
Illinois CancerCare-Ottawa Clinic, Ottawa
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Illinois CancerCare-Peru, Peru
Valley Radiation Oncology, Peru
Illinois CancerCare-Princeton, Princeton
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Carle Cancer Center, Urbana
Illinois CancerCare - Washington, Washington
IndianaNorthwest Cancer Center - Crown Point, Crown Point
Northwest Oncology LLC, Dyer
Northwest Cancer Center - Hobart, Hobart
Saint Mary Medical Center, Hobart
Saint Catherine Hospital, Indianapolis
The Community Hospital, Munster
Women's Diagnostic Center - Munster, Munster
Northwest Cancer Center - Valparaiso, Valparaiso
IowaMary Greeley Medical Center, Ames
McFarland Clinic - Ames, Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
Mercy Hospital, Cedar Rapids
Oncology Associates at Mercy Medical Center, Cedar Rapids
Mercy Cancer Center-West Lakes, Clive
Greater Regional Medical Center, Creston
Broadlawns Medical Center, Des Moines
Iowa Methodist Medical Center, Des Moines
Mercy Medical Center - Des Moines, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
McFarland Clinic - Trinity Cancer Center, Fort Dodge
McFarland Clinic - Marshalltown, Marshalltown
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
Mercy Medical Center-West Lakes, West Des Moines
KansasUniversity of Kansas Clinical Research Center, Fairway
Central Care Cancer Center - Garden City, Garden City
Central Care Cancer Center - Great Bend, Great Bend
HaysMed, Hays
University of Kansas Cancer Center, Kansas City
Lawrence Memorial Hospital, Lawrence
The University of Kansas Cancer Center - Olathe, Olathe
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Indian Creek Campus, Overland Park
Mercy Hospital Pittsburg, Pittsburg
Salina Regional Health Center, Salina
University of Kansas Health System Saint Francis Campus, Topeka
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyCommonSpirit Saint Joseph Hospital - Bardstown, Bardstown
Commonwealth Cancer Center-Corbin, Corbin
CommonSpirit Saint Joseph Hospital - Lexington, Lexington
CommonSpirit Saint Joseph Medical Center - East Lexington, Lexington
Saint Joseph Radiation Oncology Resource Center, Lexington
CommonSpirit Saint Joseph Hospital London, London
CommonSpirit Saint Joseph Hospital Mount Sterling, Mount Sterling
MaineMaineHealth Cancer Care and IV Therapy - Brunswick, Brunswick
MaineHealth LincolnHealth Hospital, Damariscotta
MaineHealth Cancer Care Center of York County, Sanford
MaineHealth Maine Medical Center- Scarborough, Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland, South Portland
MarylandChristiana Care - Union Hospital, Elkton
MichiganMyMichigan Medical Center Gratiot, Alma
MyMichigan Medical Center Alpena, Alpena
Trinity Health IHA - Obstetrics and Gynecology West Arbor, Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Bronson Battle Creek, Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health Medical Center - Brighton, Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health Medical Center - Canton, Canton
Chelsea Hospital, Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Hematology Oncology Consultants-Clarkston, Clarkston
Henry Ford Health Saint John Hospital, Detroit
Henry Ford River District Hospital, East China Township
OSF Saint Francis Hospital and Medical Group, Escanaba
Cancer Hematology Centers - Flint, Flint
Genesee Hematology Oncology PC, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
MyMichigan Medical Center Gladwin, Gladwin
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast, Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander, Grosse Pointe Woods
Beacon Kalamazoo, Kalamazoo
Beacon Kalamazoo Cancer Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Henry Ford Saint John Hospital - Macomb Medical, Macomb
Henry Ford Warren Hospital - Breast Macomb, Macomb
Schoolcraft Memorial Hospital, Manistique
MyMichigan Medical Center Midland, Midland
MyMichigan Medical Center Mount Pleasant, Mount Pleasant
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Michigan Healthcare Professionals Pontiac, Pontiac
Newland Medical Associates-Pontiac, Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Corewell Health Reed City Hospital, Reed City
MyMichigan Medical Center Saginaw, Saginaw
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
MyMichigan Medical Center Tawas, Tawas City
Munson Medical Center, Traverse City
Henry Ford Health Warren Hospital, Warren
Henry Ford Madison Heights Hospital - Breast, Warren
Henry Ford Warren Hospital - GLCMS, Warren
University of Michigan Health - West, Wyoming
Huron Gastroenterology PC, Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaRiverwood Healthcare Center, Aitkin
Essentia Health - Baxter Clinic, Baxter
Sanford Joe Lueken Cancer Center, Bemidji
Essentia Health Saint Joseph's Medical Center, Brainerd
Minnesota Oncology - Burnsville, Burnsville
Minnesota Oncology Hematology PA-Chaska, Chaska
Mercy Hospital, Coon Rapids
Minnesota Oncology - Coon Rapids, Coon Rapids
Essentia Health - Saint Joseph's Crosslake Clinic, Crosslake
Essentia Health - Deer River Clinic, Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes
Essentia Health Cancer Center, Duluth
Essentia Health Saint Mary's Medical Center, Duluth
Miller-Dwan Hospital, Duluth
Fairview Southdale Hospital, Edina
Minnesota Oncology - Edina, Edina
Essentia Health - Ely Clinic, Ely
Essentia Health - Fosston, Fosston
Essentia Health Hibbing Clinic, Hibbing
Essentia Health - International Falls Clinic, International Falls
Fairview Clinics and Surgery Center Maple Grove, Maple Grove
Minnesota Oncology - Maple Grove, Maple Grove
Minnesota Oncology Hematology PA-Maplewood, Maplewood
Saint John's Hospital - Healtheast, Maplewood
Abbott-Northwestern Hospital, Minneapolis
Hennepin County Medical Center, Minneapolis
Essentia Health - Moose Lake Clinic, Moose Lake
New Ulm Medical Center, New Ulm
Essentia Health - Park Rapids, Park Rapids
Essentia Health - Saint Joseph's Pequot Lakes Clinic, Pequot Lakes
Essentia Health - Saint Joseph's Pine River Clinic, Pine River
Fairview Northland Medical Center, Princeton
North Memorial Medical Health Center, Robbinsdale
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Essentia Health Sandstone, Sandstone
Saint Francis Regional Medical Center, Shakopee
Essentia Health - Saint Joseph's Staples Clinic, Staples
Lakeview Hospital, Stillwater
Sanford Thief River Falls Medical Center, Thief River Falls
Essentia Health Virginia Clinic, Virginia
Ridgeview Medical Center, Waconia
Rice Memorial Hospital, Willmar
Minnesota Oncology Hematology PA-Woodbury, Woodbury
Sanford Cancer Center Worthington, Worthington
Fairview Lakes Medical Center, Wyoming
MississippiBaptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus
Baptist Cancer Center-Grenada, Grenada
Baptist Memorial Hospital and Cancer Center-Union County, New Albany
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven
MissouriMercy Oncology and Hematology - Clayton-Clarkson, Ballwin
Central Care Cancer Center - Bolivar, Bolivar
Cox Cancer Center Branson, Branson
Mercy Cancer Center - Cape Girardeau, Cape Girardeau
Saint Francis Medical Center, Cape Girardeau
Parkland Health Center - Farmington, Farmington
Freeman Health System, Joplin
Mercy Hospital Joplin, Joplin
University Health Truman Medical Center, Kansas City
University of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
Liberty Hospital, Liberty
Lake Regional Hospital, Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology, Rolla
Phelps Health Delbert Day Cancer Institute, Rolla
Heartland Regional Medical Center, Saint Joseph
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
CoxHealth South Hospital, Springfield
Mercy Hospital Springfield, Springfield
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Mercy Infusion Center - Chippewa, St Louis
Missouri Baptist Medical Center, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
Mercy Hospital Washington, Washington
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Hi-Line Sletten Cancer Center, Havre
Benefis Helena Specialty Center, Helena
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaCHI Health Saint Francis, Grand Island
CHI Health Good Samaritan, Kearney
Alegent Health Bergan Mercy Medical Center, Omaha
Alegent Health Immanuel Medical Center, Omaha
Alegent Health Lakeside Hospital, Omaha
New MexicoUniversity of New Mexico Cancer Center, Albuquerque
New YorkJames J Peters VA Medical Center, The Bronx
North CarolinaFirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst
North DakotaSanford Bismarck Medical Center, Bismarck
Essentia Health Cancer Center-South University Clinic, Fargo
Sanford Broadway Medical Center, Fargo
Sanford Medical Center Fargo, Fargo
Sanford Roger Maris Cancer Center, Fargo
Sanford South University Medical Center, Fargo
Southpointe-Sanford Medical Center Fargo, Fargo
Essentia Health - Jamestown Clinic, Jamestown
OhioBethesda North Hospital, Cincinnati
Good Samaritan Hospital - Cincinnati, Cincinnati
TriHealth Cancer Institute-Anderson, Cincinnati
TriHealth Cancer Institute-Westside, Cincinnati
OklahomaMercy Hospital Oklahoma City, Oklahoma City
OregonSaint Alphonsus Cancer Care Center-Baker City, Baker City
Saint Alphonsus Cancer Care Center-Ontario, Ontario
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Lehigh Valley Hospital - Muhlenberg, Bethlehem
Christiana Care Health System-Concord Health Center, Chadds Ford
Geisinger Medical Center, Danville
Geisinger Cancer Center Dickson City, Dickson City
Pocono Medical Center, East Stroudsburg
Geisinger Medical Center-Cancer Center Hazleton, Hazleton
Lehigh Valley Hospital-Hazleton, Hazleton
Geisinger Medical Oncology-Lewisburg, Lewisburg
Geisinger Cancer Services-Pottsville, Pottsville
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
South CarolinaPrisma Health Cancer Institute - Spartanburg, Boiling Springs
Prisma Health Cancer Institute - Easley, Easley
Prisma Health Cancer Institute - Butternut, Greenville
Prisma Health Cancer Institute - Eastside, Greenville
Prisma Health Cancer Institute - Faris, Greenville
Prisma Health Cancer Institute - Greer, Greer
Prisma Health Cancer Institute - Seneca, Seneca
South DakotaSanford Cancer Center Oncology Clinic, Sioux Falls
Sanford USD Medical Center - Sioux Falls, Sioux Falls
TennesseeBaptist Memorial Hospital and Cancer Center-Collierville, Collierville
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis
VirginiaVCU Massey Comprehensive Cancer Center, Richmond
VCU Community Memorial Health Center, South Hill
VCU Health Tappahannock Hospital, Tappahannock
WashingtonSaint Joseph Medical Center Hematology and Oncology - Silverdale, Silverdale
WisconsinAspirus Cancer Care-Antigo-Volm Cancer Center, Antigo
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton, Appleton
Duluth Clinic Ashland, Ashland
Northwest Wisconsin Cancer Center, Ashland
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield, Brookfield
Ascension Calumet Hospital-Chilton, Chilton
Ascension Southeast Wisconsin Hospital - Franklin, Franklin
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson, Franklin
Saint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
Essentia Health-Hayward Clinic, Hayward
Tamarack Health Hayward Medical Center, Hayward
Gundersen Lutheran Medical Center, La Crosse
Aspirus Medford Hospital, Medford
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon, Mequon
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus, Milwaukee
Ascension Saint Francis Hospital-Milwaukee, Milwaukee
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee, Milwaukee
Cancer Center of Western Wisconsin, New Richmond
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh, Oshkosh
Ascension All Saints Hospital-Spring Street-Racine, Racine
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center, Rhinelander
Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan
Sheboygan Physicians Group, Sheboygan
Essentia Health-Spooner Clinic, Spooner
Aspirus Cancer Care - Stevens Point, Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay
Essentia Health Saint Mary's Hospital - Superior, Superior
Aspirus Cancer Care-Wausau, Wausau
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa, Wauwatosa
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids
WyomingMemorial Hospital of Laramie County, Cheyenne
Billings Clinic-Cody, Cody

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.