Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC)

Who is this study for? Patients with stage II gastric cancer
What treatments are being studied? S-1
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study aims to compare the efficacy and safety of S-1 for 9 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Hypothesis: For gastric patients after D2 resection, S-1 for 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The lower age limit of research subjects 18 years old and upper age limit of 75 years old.

• Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence

• R0 surgery with lymphadenectomy

• Without any other malignancies

• ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months

• No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram (WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L, PLT≥100 x 109 /L and HGB≥90g/L).

Locations
Other Locations
China
Anqing Municipal Hospital
RECRUITING
Anqing
Second Affiliated Hospital, School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Jiangxi Provincial Cancer Hospital
RECRUITING
Nanchang
Dazhi Xu
RECRUITING
Shanghai
First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Contact Information
Primary
Dazhi Xu, PHD, MD
xudzh@sysucc.org.cn
(+86) 020-87343737
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 1006
Treatments
Experimental: S-1 for 9 months
S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection
Active_comparator: S-1 for 1 year
S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov