CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Trifluridine and Tipiracil Hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04097028
NCT04097028Phase 2Completed
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Use of Trifluridine/Tipiracil (TAS-102) and Oxaliplatin as Induction Chemotherapy in Resectable Esophageal and Gastroesophageal Junction (GEJ) Adenocarcinoma

Roswell Park Cancer Institute·interventional·Posted Sep 20, 2019·Updated Apr 29, 2025

In Brief

A Phase 2 clinical trial evaluating Trifluridine and Tipiracil Hydrochloride and Oxaliplatin for Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8 and 15 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with esophageal or gastroesophageal junction adenocarcinoma that can be removed by surgery (resectable). Drugs used in chemotherapy, such as trifluridine/tipiracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage III Esophageal Adenocarcinoma AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
CountriesUnited States
CollaboratorsNational Comprehensive Cancer Network

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 20, 2019
Enrollment StartDec 20, 2019
Primary CompletionDec 16, 2022
Study CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.8 years ago

Interventions

Trifluridine and Tipiracil Hydrochloridedrug

Given PO

Oxaliplatindrug

Given IV