NCT01542294

Brief Summary

The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

October 16, 2011

Last Update Submit

June 12, 2016

Conditions

Gastric Cancer

Keywords

gastric cancerS-1oxaliplatinadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • chemotherapy complete rate

    percentage of patients who completed eight cycles of chemotherapy

    6 months

Secondary Outcomes (3)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    3 years

  • recurrence-free survival(RFS)

    3 years

  • overall survival(OS)

    3 years

Study Arms (1)

treatment

EXPERIMENTAL

s1+oxaliplatin

Drug: s1Drug: Oxaliplatin

Interventions

s1DRUG

60-90mg/m2/d P.O. day 1-14, repeated every 21 days

Also known as: TS-1
treatment
OxaliplatinDRUG

130mg/m2 d1 repeated every 21 days

Also known as: Eloxatin
treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Histologically proven adenocarcinoma of the stomach
  • Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
  • Stage II, III (AJCC 7th edition)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • No prior chemotherapy or radiotherapy
  • Adequate bone marrow, renal, and liver function

You may not qualify if:

  • Any evidence of metastatic disease (including presence of tumor cells in the ascites).
  • Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  • Pregnant or lactating women.
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
  • Organ allografts requiring immunosuppressive therapy.
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology,Cancer hospital and Institute,CAMS

Beijing, 100021, China

Location

Related Publications (1)

  • Wang G, Zhao J, Song Y, Zhang W, Sun Y, Zhou A, Huang J, Du F, Yang L. Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer. BMC Cancer. 2018 May 9;18(1):547. doi: 10.1186/s12885-018-4480-9.

    PMID: 29743043DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)titanium silicideOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Lin Yang, MD

    Department of Medical Oncology,Cancer Hospital and Institute,CAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

October 16, 2011

First Posted

March 2, 2012

Study Start

June 1, 2011

Primary Completion

September 1, 2014

Study Completion

April 1, 2017

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

CN(1)