Study Stopped
The number of patients enrolled was much less than expected
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer
RESCUE-GC
A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer
1 other identifier
interventional
29
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Apr 2017
15 active sites
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
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedDecember 3, 2024
September 1, 2021
4.4 years
August 4, 2016
November 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival
5 years
Secondary Outcomes (2)
overall survival
up to 5 years
Incidence of Treatment-Emergent Adverse Events [Safety]
1 year
Study Arms (2)
A: postoperative Oxaliplatin plus S-1
EXPERIMENTALPatients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later. Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40\~60mg bid, po, d1\~14, q3W (6 months)
B: postoperative S-1 only
ACTIVE COMPARATORPatients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later. S-1: 40\~60mg bid, po, d1\~14, q3W (12 months)
Interventions
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
16 cycles of adjuvant chemotherapy with S-1 only
Eligibility Criteria
You may qualify if:
- 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 ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Cancer Hospital Chinese Acadamy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital
Beijing, Beijing Municipality, 100053, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Nanjing General Hospital
Nanjing, Jiangsu, 210002, China
The First Affiliated Hospital of Daliang Medical University
Daliang, Liaoning, 116011, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
Hu X, Chen L, Du Y, Fan B, Bu Z, Wang X, Ye Y, Zhang Z, Xiao G, Li F, He Q, Li G, Shen X, Xiong B, Zhu L, Liu J, Liu L, Wu T, Zhou J, Zhang J, Zhao G, Wang X, Liang P, Wang X, Zhang Y, Wu X, Zhang J, Ji X, Zong X, Fu T, Jia Z, Ji J. Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial. Chin J Cancer Res. 2017 Apr;29(2):144-148. doi: 10.21147/j.issn.1000-9604.2017.02.07.
PMID: 28536493DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jiafu Ji, MD
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 16, 2016
Study Start
April 24, 2017
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
December 3, 2024
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share