Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer (RESCUE-GC)

  • STATUS
    Recruiting
  • End date
    Feb 10, 2024
  • participants needed
    564
  • sponsor
    Beijing Cancer Hospital
Updated on 25 February 2022
gastrectomy
oxaliplatin
lymphadenectomy
cancer chemotherapy
adjuvant chemotherapy
immunostimulants
d2 lymph node dissection

Summary

The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

Description

The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Details
Condition Gastric Cancer
Treatment Oxaliplatin plus S-1, S-1 only
Clinical Study IdentifierNCT02867839
SponsorBeijing Cancer Hospital
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

sign written informed consent form
age 18 years, 69 years
ECOG status: 0~2
pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
negative peritoneal cytology
underwent curative distal gastrectomy with D2 lymph node dissection
no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
adequate organ function as defined below: Hematologic ANC 2 _109/L, Platelets 100_ 109/L, AST and ALT 2.5ULN, TBIL 1.5ULN

Exclusion Criteria

be enrolled in other clinical trials
underwent prior antitumor treatment
allergic reaction to S-1 or oxaliplatin
abnormal GI tract function
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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