NCT00252161

A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Haruhiko Fukuda · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.

Detailed description

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Conditions

• Gastric Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Gastrectomy with more than D2 dissection	Gastrectomy with more than D2 dissection
DRUG	Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy	Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Timeline

• Start date: 2005-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2005-11-11
• Last updated: 2016-09-22

Locations

35 sites across 1 country: Japan