Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Recruiting · NCT07283939 · Interventional (participants receive a specific treatment) · Lead sponsor: Alliance for Clinical Trials in Oncology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
60 locations listed across 37 US states.
- Fairbanks Memorial Hospital - Fairbanks, Alaska, United States
- 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
- CommonSpirit Saint Anthony Hospital Cancer Center - 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
- Northside Hospital - Atlanta, Georgia, 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
Showing 60 of 363 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →