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

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ClinicalTrials.gov Identifier: NCT02867839
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Biao Fan, MD, PhD, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Oxaliplatin plus S-1 Drug: S-1 only Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : February 10, 2022
Estimated Study Completion Date : February 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: A: postoperative Oxaliplatin plus S-1

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)

Drug: Oxaliplatin plus S-1
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
Other Name: SOX

Active Comparator: B: postoperative S-1 only

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)

Drug: S-1 only
16 cycles of adjuvant chemotherapy with S-1 only
Other Name: S-1




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 5 years ]
    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

  2. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 1 year ]
    The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867839


Contacts
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Contact: Jiafu Ji, MD 0086-10-88196391 jiafuj@hotmail.com
Contact: Biao Fan, MD, Ph.D 0086-10-88196970 fanbiao1986@163.com

Locations
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China, Beijing
Cancer Hospital Chinese Acadamy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Dongbing Zhao, MD         
Contact: Lin Yang, MD         
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Xin Wang, MD    13691478989    wangxin_guo@hotmail.com   
Contact: Tao Wu, MD    13671063600    drwutao@aliyun.com   
Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Yingjiang Ye, MD    13911133682    yeyingjiang@pkuph.edu.cn   
Contact: Jing Zhou, MD       zhoujing-rmyy@126.com   
Beijing Friendship Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Zhongtao Zhang, MD    13801060364    zhangzht@medmail.com.cn   
Xuanwu Hospital Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Fei Li, MD       fli36@hotmail.com   
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jiafu Ji, MD    0086-01-88196391    jiafuj@hotmail.com   
Contact: Biao Fan, MD, PhD    0086-01-88196970    fanbiao1986@163.com   
Principal Investigator: Jiafu Ji, MD         
Sub-Investigator: Zhaode Bu, MD         
Sub-Investigator: Biao Fan, MD         
Beijing Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Gang Xiao, MD       xgbj@sina.com   
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Lin Chen, MD    13801290395    chenlinbj@vip.sina.com   
China, Hubei
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430071
Contact: Bin Xiong, MD    13886029351    binxiong1961@163.com   
China, Jiangsu
Nanjing General Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210002
Contact: Guoli Li, MD    13851559752    13851559752@163.com   
China, Liaoning
The First Affiliated Hospital of Daliang Medical University Recruiting
Daliang, Liaoning, China, 116011
Contact: Xiang Hu, MD       sunnyliangpin@163.com   
China, Shandong
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China, 250012
Contact: Qingsi He, MD    13791122955    13791122955@163.com   
Contact: Lian Liu, MD       tounao@126.com   
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yian Du, MD       duyajim@126.com   
The First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Xiaolei Chen, MD    15888405786    99953095@qq.com   
Contact: Wenyi Wu, MD    15888405786    99953095@qq.com   
The Second Affiliated Hospital of Wenzhou Medical University Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Xian Shen, MD    13968888872    13968888872@163.com   
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Study Chair: Jiafu Ji, MD Beijing Cancer Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biao Fan, MD, PhD, Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02867839     History of Changes
Other Study ID Numbers: RESCUE-GC-2016
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biao Fan, MD, PhD, Beijing Cancer Hospital:
Gastric cancer
Adjuvant chemotherapy
S1
Oxaliplatin
Survival

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents