Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer: SOS

Summary

The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the first-line treatment for AGC patients.

The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1 plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is progression-free survival. This is an open label, randomized, multi-center, non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.

Conditions

• Advanced Gastric Cancer

Interventions

DRUG

S-1 and cisplatin

S-1: 80 mg/m2/day po on Days 1-14 cisplatin: 60 mg/m2 iv on Day 1

DRUG

S-1 and cisplatin

S-1: 80 mg/day with BSA less than 1.25 m2, 100 mg/day with BSA more than 1.25 m2 and less than 1.5 m2, 120 mg/day with BSA more than 1.5 m2 on Days 1-21 and cisplatin: 60 mg/m2 iv on Day 1 or 8

Sponsors & Collaborators

• Samsung Medical Center

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Seoul Veterans Hospital

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Ulsan University Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Korea Cancer Center Hospital

  collaborator OTHER

• Yeungnam University College of Medicine

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Asan Medical Center

  lead OTHER

Principal Investigators

• Yoon-Koo Kang, MD, PhD · Asan Medical Center, Seoul, Korea

• Won Ki Kang, M.D.PhD. · Samsung Medical Center, Seoul, Korea

• Jong Kwang Kim, M.D.PhD · Kyungpook National University Hospital, Korea

• Young Iee Park, M.D.PhD · National Cancer Center, Korea

• Jin Ho Baek, M.D.PhD. · Ulsan University Hospital, Korea

• Chang Hak Sohn, M.D.PhD. · Inje University Pusan Paik Hospital, Korea

• Eun Ki Song, M.D.PhD. · Chonbuk National University Hospital, Korea

• Dong Bok Shin, M.D.PhD. · Gachon University Gil Medical Center

• Sung Hyun Yang, M.D.PhD. · Korea Cancer Center Hospital

• Kyung Hee Lee, M.D.PhD. · Yeungnam University College of Medicine

• Dae Young Zang, M.D.PhD · Hallym University Medical Center

• Ik-Joo Chung, M.D.PhD · Chonnam National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• South Korea

Study Locations