Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
NCT07283939 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2026-05-11
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.
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
-
Given IV
- DRUG
-
Folinic Acid
Given IV
- DRUG
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Gabriel A. Brooks, MD, MPH · Alliance for Clinical Trials in Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-13
- Primary Completion
- 2030-05-01
- Completion
- 2030-05-02
Countries
- United States
- Puerto Rico
Study Locations
More Related Trials
-
Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
NCT00008294 ·Status: COMPLETED ·Phase: PHASE1
-
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
NCT01643499 ·Status: COMPLETED ·Phase: PHASE1
-
FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
NCT00646607 ·Status: COMPLETED ·Phase: PHASE3
-
Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
NCT00537823 ·Status: TERMINATED ·Phase: PHASE2
-
Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer
NCT02002195 ·Status: UNKNOWN
-
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
NCT05546411 ·Status: TERMINATED ·Phase: PHASE2
-
FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
NCT01413022 ·Status: COMPLETED ·Phase: PHASE1
-
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
NCT06078709 ·Status: RECRUITING ·Phase: PHASE2
-
Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
NCT02345746 ·Status: WITHDRAWN ·Phase: PHASE2
-
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
NCT00514020 ·Status: COMPLETED ·Phase: PHASE2
-
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
NCT00059930 ·Status: COMPLETED ·Phase: PHASE1
-
Oxaliplatin and 5-Fluorouracil With or Without Docetaxel in Elderly Patients (>65 y) With Stomach and Esophagus Cancer
NCT00737373 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
NCT00039611 ·Status: COMPLETED ·Phase: NA
-
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
NCT02366819 ·Status: SUSPENDED ·Phase: PHASE4
-
FOLFIRINOX + NIS793 in Pancreatic Cancer
NCT05417386 ·Status: TERMINATED ·Phase: PHASE1
-
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
NCT04393584 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
NCT00008281 ·Status: UNKNOWN ·Phase: PHASE3
-
Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer
NCT00826800 ·Status: TERMINATED ·Phase: NA
-
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
NCT03773367 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma
NCT01443065 ·Status: COMPLETED ·Phase: PHASE2
-
Preoperative Chemosensitivity Testing to Predict Treatment Benefit in Adjuvant Stage III Colon Cancer
NCT00994864 ·Status: COMPLETED ·Phase: NA
-
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
NCT00004931 ·Status: COMPLETED ·Phase: PHASE3
-
Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer
NCT00268463 ·Status: TERMINATED ·Phase: PHASE3
-
Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
NCT02333188 ·Status: COMPLETED ·Phase: PHASE1
-
PHASE III RANDOMISED TRIAL to EVALUATE FOLFOX with or WITHOUT DOCETAXEL (TFOX) AS 1st LINE CHEMOTHERAPY for LOCALLY ADVANCED or METASTATIC OESOPHAGO-GASTRIC CARCINOMA
NCT03006432 ·Status: COMPLETED ·Phase: PHASE3