Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma

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.

Timeline

Start

2019-12-20

Primary completion

2022-12-16

Completion

2025-02-05

Outcome

Missed primary endpoint

paper Since we could not meet our predefined pCR rate at the interim analysis, the study was closed. PMID 40200573 ↗

paper IC with trifluridine/tipiracil and oxaliplatin followed by CRT did not improve pCR rate PMID 40200573 ↗

Publications

• Mukherjee S, Fujiwara Y, Fountzilas C, Pattnaik H, Chatley S, Vadehra D, Kukar M, Attwood K, George A, Advani S, Yu H, Catalfamo K, Brown A, Spickard E, Fungtammasan A, George S, Liao CY, Iyer R, Hatoum H. Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy in Resectable Esophageal and Gastroesophageal Junction Adenocarcinoma: A Phase II Study. Cancer Med. 2025 Apr;14(7):e70835. doi: 10.1002/cam4.70835.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxaliplatin	Small molecule	—	Intravenous
Subject	Trifluridine/Tipiracil	Unknown	—	Oral

Indications