NCT04937738

Perioperative Chemotherapy in Gastric Cancer

Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Ukrainian Society of Clinical Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	50mg/m2, d1, i.v., every 2 weeks
DRUG	Oxaliplatin	85 mg/m², d1, i.v., every 2 weeks
DRUG	Leucovorin	200 mg/m², d1, i.v., every 2 weeks
DRUG	Fluorouracil	2600 mg/m²d1 i.v. every 2 weeks
DRUG	Capecitabine	1000 mg/m² two times per day (BID), d1-14
DRUG	Oxaliplatin	130 mg/m² d1 i.v. every 3 weeks

Timeline

• Start date: 2021-07-21
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-06-24
• Last updated: 2024-11-06

Locations

1 site across 1 country: Ukraine