Health Trials

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

ConditionsAmpulla of Vater CarcinomaAppendix CarcinomaCarcinoma of Unknown Primary With Gastrointestinal ProfileColon CarcinomaEsophageal CarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaMalignant Digestive System NeoplasmRectal CarcinomaSmall Intestinal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

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.

Eligibility criteria

Qualifiers

* 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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • PAGODA algorithm
  • Oxaliplatin
  • Folinic Acid
  • Fluorouracil

Treatment groups

420 Participants
are divided into 2 treatment groups

Locations

344
Guam
FHP Health Center-Guam96913, Tamuning Guam
Puerto Rico
Cancer Center-Metro Medical Center Bayamon00959-5060, Bayamón Puerto Rico
Puerto Rico Hematology Oncology Group00961, Bayamón Puerto Rico
Doctors Cancer Center00674, Manati Puerto Rico

Sponsors and collaborators

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov