Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Purpose
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.
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
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm B- PAGODA Algorithm |
Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study. |
|
|
Active Comparator Arm A- Physician Discretion |
Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study. |
|
Recruiting Locations
Phoenix, Arizona 85004
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Arroyo Grande, California 93420
Carmichael, California 95608
Carmichael, California 95608
Elk Grove, California 95758
Merced, California 95340
Rocklin, California 95765
Sacramento, California 95816
San Luis Obispo, California 93401
Santa Maria, California 93444
Stockton, California 95204
Site Public Contact
209-461-5257
Woodland, California 95695
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Durango, Colorado 81301
Durango, Colorado 81301
Lakewood, Colorado 80228
Longmont, Colorado 80501
Pueblo, Colorado 81004
Westminster, Colorado 80023
Lewes, Delaware 19958
Millville, Delaware 19967
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
Wilmington, Delaware 19801
Fort Lauderdale, Florida 33308
Tifton, Georgia 31794
Site Public Contact
800-648-1935
Boise, Idaho 83706
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Meridian, Idaho 83642
Nampa, Idaho 83687
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Alton, Illinois 62002
Site Public Contact
618-463-5623
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
Carterville, Illinois 62918
Carthage, Illinois 62321
Centralia, Illinois 62801
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Dixon, Illinois 61021
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815-285-7800
Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Kewanee, Illinois 61443
Macomb, Illinois 61455
Mattoon, Illinois 61938
Mount Vernon, Illinois 62864
Normal, Illinois 61761
Normal, Illinois 61761
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peru, Illinois 61354
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Springfield, Illinois 62702
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217-545-7929
Springfield, Illinois 62702
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800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Washington, Illinois 61571
Ames, Iowa 50010
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515-956-4132
Ames, Iowa 50010
Ankeny, Iowa 50023
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515-241-3305
Cedar Rapids, Iowa 52403
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319-365-4673
Cedar Rapids, Iowa 52403
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319-363-2690
Clive, Iowa 50325
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515-241-3305
Creston, Iowa 50801
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Des Moines, Iowa 50309
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515-241-6727
Des Moines, Iowa 50309
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Des Moines, Iowa 50314
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515-282-2200
Des Moines, Iowa 50314
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Des Moines, Iowa 50314
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Fort Dodge, Iowa 50501
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Marshalltown, Iowa 50158
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515-956-4132
Waukee, Iowa 50263
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515-241-3305
West Des Moines, Iowa 50266
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515-241-3305
Garden City, Kansas 67846
Great Bend, Kansas 67530
Pittsburg, Kansas 66762
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888-446-3729
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Mount Sterling, Kentucky 40353
Elkton, Maryland 21921
Alma, Michigan 48801
Alpena, Michigan 49707
Ann Arbor, Michigan 48103
Ann Arbor, Michigan 48106
Brighton, Michigan 48114
Brighton, Michigan 48114
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Gladwin, Michigan 48624
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
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Lansing, Michigan 48912
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Macomb, Michigan 48044
Macomb, Michigan 48044
Midland, Michigan 48670
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Pontiac, Michigan 48341
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Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saginaw, Michigan 48601
Tawas City, Michigan 48764
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
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218-828-2880
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Chaska, Minnesota 55318
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Crosslake, Minnesota 56442
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218-692-1010
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Edina, Minnesota 55435
Ely, Minnesota 55731
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218-365-7900
Fosston, Minnesota 56542
Hibbing, Minnesota 55746
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218-786-3308
International Falls, Minnesota 56649
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218-283-9431
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Moose Lake, Minnesota 55767
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218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Pequot Lakes, Minnesota 56472
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218-568-4416
Pine River, Minnesota 56474
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218-587-4416
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Staples, Minnesota 56479
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218-894-7870
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
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605-312-3320
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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Wyoming, Minnesota 55092
Grenada, Mississippi 38901
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
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888-446-3729
Bolivar, Missouri 65613
Branson, Missouri 65616
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417-269-4520
Cape Girardeau, Missouri 63703
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Cape Girardeau, Missouri 63703
Farmington, Missouri 63640
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314-996-5569
Joplin, Missouri 64804
Joplin, Missouri 64804
Osage Beach, Missouri 65065
Rolla, Missouri 65401
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573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Sainte Genevieve, Missouri 63670
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Springfield, Missouri 65804
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Springfield, Missouri 65807
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St Louis, Missouri 63109
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St Louis, Missouri 63128
St Louis, Missouri 63131
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St Louis, Missouri 63141
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Sullivan, Missouri 63080
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Sunset Hills, Missouri 63127
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Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Albuquerque, New Mexico 87106
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
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Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Ontario, Oregon 97914
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Chadds Ford, Pennsylvania 19317
East Stroudsburg, Pennsylvania 18301
Hazleton, Pennsylvania 18201
Boiling Springs, South Carolina 29316
Easley, South Carolina 29640
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Greenville, South Carolina 29615
Greer, South Carolina 29650
Seneca, South Carolina 29672
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Silverdale, Washington 98383
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
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218-568-4416
New Richmond, Wisconsin 54017
Oconto Falls, Wisconsin 54154
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Spooner, Wisconsin 54801
Sturgeon Bay, Wisconsin 54235-1495
Superior, Wisconsin 54880
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701-364-6272
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Bayamón, Puerto Rico 00959-5060
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787-395-7085
Bayamón, Puerto Rico 00961
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Manatí, Puerto Rico 00674
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San Juan, Puerto Rico 00917
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787-274-3387
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
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787-763-1296
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To compare the proportion of chemotherapy cycles with unplanned delays in patients receiving FOLFOX chemotherapy under standardized usual care (control) versus (vs) according to the PAGODA dose modification algorithm (intervention). SECONDARY OBJECTIVES: I. To compare the mean number of health care contact days (time toxicity) for patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. II. To compare the incidence moderate-to-severe neutropenia (absolute neutrophil count less than 1000/mm3 in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. III. To compare the relative dose-intensity of bolus 5-FU, oxaliplatin, and infusional 5-FU in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms, both overall and among the subgroup of participants treated with curative intent. OUTLINE: This is an interventional study. Patients are randomized to 1 of 2 arms. ARM A: Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study. ARM B: Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.