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Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

NCT02736552 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-05-08

No results posted yet for this study

Summary

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.

Conditions

Interventions

DRUG

S-1 for 6 months

6 months S-1 after D2 resection

DRUG

S-1 for 1 year

1 year S-1 after D2 resection

Sponsors & Collaborators

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Anqing Municipal Hospital

    collaborator OTHER

  • Yuebei People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    collaborator OTHER

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wannan Medical College

    collaborator OTHER

  • Lishui hospital of Zhejiang University

    collaborator UNKNOWN

  • Sun Yat-sen University

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-03-31
Completion
2023-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736552 on ClinicalTrials.gov