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A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer


Inclusion Criteria:



- informed consensus of patients

- be able to receive oral administration

- from 18 to 70 years old

- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by
pathological evidences

- without other chemotherapy and/or radiation against to the disease

- normal function of other organs including heart,liver ,kidney and so on

- Eastern Cooperative Oncology Group performance status:0~2

Exclusion Criteria:

- history of other malignancy

- allergic reaction to S-1 or oxaliplatin

- be enrolling in other clinical trials

- abnormal GI tract function

- dysfunction of other organs

- female in pregnancy or lactation,or refuse to receive Contraception measures during
chemotherapy

- other situation to be judged not adaptive to the study by investigators

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

mortality

Outcome Description:

5 year after the last patients enrolled

Outcome Time Frame:

5 year

Safety Issue:

Yes

Principal Investigator

Zhiwei Zhou, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

SunYat-sen University

Authority:

China: Food and Drug Administration

Study ID:

SYSUCCGPS

NCT ID:

NCT01795027

Start Date:

September 2011

Completion Date:

June 2018

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • chemotherapy
  • D2 resection
  • S-1
  • Stomach Neoplasms

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