NCT01946061

Brief Summary

Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

September 12, 2013

Last Update Submit

August 18, 2016

Conditions

Advanced Gastric Cancer

Keywords

Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival

    3-year disease-free survival will be assessed by imaging study including CT and PET.

    3 years from the surgery

Study Arms (1)

Treatment group

EXPERIMENTAL
Drug: S-1 plus oxaliplatin

Interventions

S-1 plus oxaliplatinDRUG

Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.

Treatment group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, between 19 and 75
  • Histologically proven advanced gastric cancer
  • R0 resection after D2 gastrectomy
  • Stage III (according to the AJCC 7th criteria)
  • ECOG status 0 to 2

You may not qualify if:

  • Malignancy history other than gastric cancer
  • Previous chemotherapy history for gastric cancer
  • Previous radiotherapy history for gastric cancer
  • Pregnancy or breast milk feeding
  • Grade 3 or more of neuropathy
  • Active infection
  • Severe hepatic dysfunction
  • Severe renal dysfunction
  • Severe bone marrow dysfunction
  • Significant neurologic or psychologic disease
  • Inadequate condition for receiving chemotherapy due to significant systemic disease
  • Patients who receives drugs which can be interacted with S-1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severnace Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

    PMID: 17978289BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 19, 2013

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

KR(1)