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

Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02867839
• Other study ID #: RESCUE-GC-2016
• Status: Recruiting
• Phase: Phase 3
• Start date: April 24, 2017
• Est. completion date: February 10, 2024

Study information

• Verified date: December 2018
• Source: Beijing Cancer Hospital
• Contact: Jiafu Ji, MD
• Phone: 0086-10-88196391
• Email: jiafuj[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 564
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin plus S-1
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
• S-1 only
16 cycles of adjuvant chemotherapy with S-1 only

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Acadamy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Xuanwu Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Daliang Medical University	Daliang	Liaoning
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Nanjing General Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		5 years
Secondary	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	up to 5 years
Secondary	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	1 year