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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin plus S-1
S-1 only
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Adjuvant chemotherapy, S1, Oxaliplatin, Survival

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

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

Sites / Locations

  • Cancer Hospital Chinese Acadamy of Medical SciencesRecruiting
  • Peking University First Hospital
  • Peking University People's Hospital
  • Beijing Friendship Hospital
  • Xuanwu Hospital
  • Beijing Cancer HospitalRecruiting
  • Beijing Hospital
  • Chinese PLA General Hospital
  • Zhongnan Hospital of Wuhan University
  • Nanjing General Hospital
  • The First Affiliated Hospital of Daliang Medical UniversityRecruiting
  • Qilu Hospital of Shandong University
  • Zhejiang Cancer HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: postoperative Oxaliplatin plus S-1

B: postoperative S-1 only

Arm Description

Patients 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)

Patients 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)

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival
To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Incidence of Treatment-Emergent Adverse Events [Safety]
The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX

Full Information

First Posted
August 4, 2016
Last Updated
December 11, 2018
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02867839
Brief Title
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer
Acronym
RESCUE-GC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
February 10, 2022 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Adjuvant chemotherapy, S1, Oxaliplatin, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: postoperative Oxaliplatin plus S-1
Arm Type
Experimental
Arm Description
Patients 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)
Arm Title
B: postoperative S-1 only
Arm Type
Active Comparator
Arm Description
Patients 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)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin plus S-1
Other Intervention Name(s)
SOX
Intervention Description
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
Intervention Type
Drug
Intervention Name(s)
S-1 only
Other Intervention Name(s)
S-1
Intervention Description
16 cycles of adjuvant chemotherapy with S-1 only
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Description
To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Time Frame
up to 5 years
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ≤ 2.5×ULN, TBIL ≤ 1.5×ULN. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiafu Ji, MD
Phone
0086-10-88196391
Email
jiafuj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Biao Fan, MD, Ph.D
Phone
0086-10-88196970
Email
fanbiao1986@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital Chinese Acadamy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongbing Zhao, MD
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
13691478989
Email
wangxin_guo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tao Wu, MD
Phone
13671063600
Email
drwutao@aliyun.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjiang Ye, MD
Phone
13911133682
Email
yeyingjiang@pkuph.edu.cn
First Name & Middle Initial & Last Name & Degree
Jing Zhou, MD
Email
zhoujing-rmyy@126.com
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongtao Zhang, MD
Phone
13801060364
Email
zhangzht@medmail.com.cn
Facility Name
Xuanwu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li, MD
Email
fli36@hotmail.com
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD
Phone
0086-01-88196391
Email
jiafuj@hotmail.com
First Name & Middle Initial & Last Name & Degree
Biao Fan, MD, PhD
Phone
0086-01-88196970
Email
fanbiao1986@163.com
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD
First Name & Middle Initial & Last Name & Degree
Zhaode Bu, MD
First Name & Middle Initial & Last Name & Degree
Biao Fan, MD
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Xiao, MD
Email
xgbj@sina.com
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, MD
Phone
13801290395
Email
chenlinbj@vip.sina.com
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Xiong, MD
Phone
13886029351
Email
binxiong1961@163.com
Facility Name
Nanjing General Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoli Li, MD
Phone
13851559752
Email
13851559752@163.com
Facility Name
The First Affiliated Hospital of Daliang Medical University
City
Daliang
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Hu, MD
Email
sunnyliangpin@163.com
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingsi He, MD
Phone
13791122955
Email
13791122955@163.com
First Name & Middle Initial & Last Name & Degree
Lian Liu, MD
Email
tounao@126.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yian Du, MD
Email
duyajim@126.com
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolei Chen, MD
Phone
15888405786
Email
99953095@qq.com
First Name & Middle Initial & Last Name & Degree
Wenyi Wu, MD
Phone
15888405786
Email
99953095@qq.com
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Shen, MD
Phone
13968888872
Email
13968888872@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28536493
Citation
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.
Results Reference
derived

Learn more about this trial

Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

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