Perioperative Chemotherapy in Gastric Cancer

Phase 2 Terminated 69 enrolled Ukrainian Society of Clinical Oncology

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

Timeline

Start: 2021-07-21
Primary completion: 2023-02-01
Completion: 2023-02-01

Outcome

Outcome not reported

Stopped: “High rate of disease progression in XELOX arm”

Publications

Dobrzhanskyi O, Kopetskyi V, Ross EA, Chernoff J, Shudrak Y, Kolesnyk A, Pepenin M, Horodetskyi A, Melnitchouk N, Kondratskyi Y. Treatment discontinuation associated with perioperative toxicity of FLOT versus XELOX chemotherapy in patients with resectable gastric cancer: prospective randomized trial (PECORINO). J Gastrointest Oncol. 2025 Jun 30;16(3):909-921. doi: 10.21037/jgo-2024-921. Epub 2025 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Docetaxel	Small molecule	50 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Comparator	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Comparator	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2600 mg/m2	Intravenous