NCT00915382

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

June 5, 2009

Last Update Submit

January 6, 2020

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    accrual of patients for 36 months, followup of the last patient for 12 months

Secondary Outcomes (1)

  • overall survival

    accrual of patients for 36 months, followup of the last patient for 12 months

Study Arms (2)

3 weekly regimen of S-1 and cisplatin

ACTIVE COMPARATOR
Drug: S-1 and cisplatin

5 weekly regimen of S-1 and cisplatin

ACTIVE COMPARATOR
Drug: S-1 and cisplatin

Interventions

S-1 and cisplatinDRUG

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

Also known as: TS-1 and cisplatin
3 weekly regimen of S-1 and cisplatin

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented metastatic or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
  • Age 18 to 74 years old
  • Performance status (ECOG scale) 0-2
  • No significant problems for oral intake and drug administration
  • At least one measurable or evaluable disease defined by RECIST
  • Adequate bone marrow function (ANC ≥ 1,500/uL, Platelet ≥ 100,000/ uL, Hb ≥ 9.0 g/dl)
  • Adequate renal function: serum creatinine ≤ UNL (if serum creatinine \> UNL, creatinine clearance should be ≥ 60 mL/min)
  • Adequate hepatic function (Total bilirubin \< 2 x UNL and AST/ALT levels \< 3 x UNL without liver metastasis,total bilirubin \< 3x ULN and AST/ALT levels \< 5 x UNL with liver metastasis)
  • Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study) and cisplatin was not used before
  • Patients should sign a written informed consent before study entry

You may not qualify if:

  • Tumor type other than adenocarcinoma
  • Previously exposed to any fluropymidine within 6 months before the study
  • Previously exposed to Platinum therapy regardless of its period and/or duration
  • Microscopic residual disease only after noncurative gastrectomy with R1 resection (resection margin positive)
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
  • Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
  • Presence of CNS metastasis
  • Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery (patient received curative operation or RFA for metastatic disease)
  • Serious illness or medical conditions:
  • Congestive heart failure (NYHA class III or IV)
  • Unstable angina or myocardial infarction within the past 12 months
  • Significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
  • Uncontrolled hypertension
  • Hepatic cirrhosis (≥ Child class B)
  • Interstitial pneumonia
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Ryu MH, Baba E, Lee KH, Park YI, Boku N, Hyodo I, Nam BH, Esaki T, Yoo C, Ryoo BY, Song EK, Cho SH, Kang WK, Yang SH, Zang DY, Shin DB, Park SR, Shinozaki K, Takano T, Kang YK; SOS study investigators. Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS). Ann Oncol. 2015 Oct;26(10):2097-101. doi: 10.1093/annonc/mdv316. Epub 2015 Jul 27.

    PMID: 26216386DERIVED

MeSH Terms

Interventions

S 1 (combination)Cisplatintitanium silicide

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Yoon-Koo Kang, MD, PhD

    Asan Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Won Ki Kang, M.D.PhD.

    Samsung Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Jong Kwang Kim, M.D.PhD

    Kyungpook National University Hospital, Korea

    PRINCIPAL INVESTIGATOR

  • Young Iee Park, M.D.PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

  • Jin Ho Baek, M.D.PhD.

    Ulsan University Hospital, Korea

    PRINCIPAL INVESTIGATOR

  • Chang Hak Sohn, M.D.PhD.

    Inje University Pusan Paik Hospital, Korea

    PRINCIPAL INVESTIGATOR

  • Eun Ki Song, M.D.PhD.

    Chonbuk National University Hospital, Korea

    PRINCIPAL INVESTIGATOR

  • Dong Bok Shin, M.D.PhD.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

  • Sung Hyun Yang, M.D.PhD.

    Korea Cancer Center Hospital

    PRINCIPAL INVESTIGATOR

  • Kyung Hee Lee, M.D.PhD.

    Yeungnam University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Dae Young Zang, M.D.PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

  • Ik-Joo Chung, M.D.PhD

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

KR(1)