Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Condition(s) studied
Investigational drug(s) / intervention(s)
PAGODA algorithm: use PAGODA algorithm to determine chemotherapy delays and dose modifications
Oxaliplatin: Given IV
Folinic Acid: Given IV
Fluorouracil: Given IV
Study summary
This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care. During standard of care treatment, chemotherapy dose changes or treatment delays are typically determined by the treating physician based on factors such as a patient's height, weight, and blood test results obtained before each treatment cycle. If certain blood counts are too low, the next cycle of chemotherapy may be delayed or adjusted. The PAGODA algorithm is a step-by-step decision-making tool designed to help health care providers determine whether chemotherapy doses should be adjusted or delayed in patients with low neutrophil or platelet counts. Researchers will compare treatment delays, dose changes, and safety outcomes between patients managed using the PAGODA algorithm and patients receiving usual care.
Eligibility
Primary outcome measure(s)
- Incidence of unplanned chemotherapy delays — From cycle 2 to 7 (Undelayed cycle length= 14 days)
Will employ a generalized linear mixed effects model with logit link function, with a random patient effect to account for clustering of cycles within patients. Will test if additional random effects are needed (e.g., provider or clinic level). Statistical significance will be assessed at the 5% level. Delays will be assessed over cycles 2 through 7, and a delay will be defined as an interval of \> 18 days since day 1 of the previous cycle. An unplanned delay will be defined as any delay that was not prospectively planned by day 3 of the previous cycle.
Trial sites (368)
| Facility | City | Region | Status |
|---|---|---|---|
| Fairbanks Memorial Hospital | Fairbanks | Alaska | Recruiting |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | Recruiting |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | Recruiting |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | Recruiting |
| CARTI Cancer Center | Little Rock | Arkansas | Recruiting |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | Recruiting |
| Mercy Cancer Center - Carmichael | Carmichael | California | Recruiting |
| Mercy San Juan Medical Center | Carmichael | California | Recruiting |
| Mercy Cancer Center - Elk Grove | Elk Grove | California | Recruiting |
| Mercy Cancer Center | Merced | California | Recruiting |
| Mercy Cancer Center - Rocklin | Rocklin | California | Recruiting |
| Mercy Cancer Center - Sacramento | Sacramento | California | Recruiting |
| Pacific Central Coast Health Center-San Luis Obispo | San Luis Obispo | California | Recruiting |
| Mission Hope Medical Oncology - Santa Maria | Santa Maria | California | Recruiting |
| Saint Joseph's Medical Center | Stockton | California | Recruiting |
| Woodland Memorial Hospital | Woodland | California | Recruiting |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | Recruiting |
| Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | Recruiting |
| Saint Francis Cancer Center | Colorado Springs | Colorado | Recruiting |
| CommonSpirit Cancer Center Mercy | Durango | Colorado | Recruiting |
| Mercy Medical Center | Durango | Colorado | Recruiting |
| CommonSpirit Saint Anthony Hospital Cancer Center | Lakewood | Colorado | Recruiting |
| Longmont United Hospital | Longmont | Colorado | Recruiting |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | Recruiting |
| Saint Anthony North Hospital | Westminster | Colorado | Recruiting |
| Beebe Medical Center | Lewes | Delaware | Recruiting |
| Beebe South Coastal Health Campus | Millville | Delaware | Recruiting |
| Helen F Graham Cancer Center | Newark | Delaware | Recruiting |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | Recruiting |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | Recruiting |
| Beebe Health Campus | Rehoboth Beach | Delaware | Recruiting |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | Recruiting |
| Holy Cross Hospital | Fort Lauderdale | Florida | Recruiting |
| Northside Hospital | Atlanta | Georgia | Recruiting |
| Tift Regional Medical Center | Tifton | Georgia | Recruiting |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | Recruiting |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | Recruiting |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | Recruiting |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | Recruiting |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | Recruiting |
+ 328 more sites — see the full list on the official registry below.
More Alliance for Clinical Trials in Oncology trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07283939 on ClinicalTrials.gov ↗ ← All trials in Mexico