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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03814759
Other study ID # 4-2015-0603
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 12, 2016
Est. completion date July 31, 2022

Study information

Verified date April 2021
Source Yonsei University
Contact Hyo Song Kim
Phone 82-2-2228-8124
Email hyosong77@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 ~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date July 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Age = 20 years old 2. Histologically confirmed gastric adenocarcinoma 3. clinical stage : resectable gastric cancer - advanced confirmed (EGD) - extramural infiltration> 1 mm (CT) - positive serosa invasion (EUS) 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. no prior chemotherapy and radiotherapy 6. measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria 7. Patients with adequate organ function 8. Signed informed consent Exclusion Criteria: 1. Metastasis esophageal invasion > 3cm 2. inoperable peritoneal seeding disease determined by exploratory laparotomy 3. T4b invading the surrounding organs 4. lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node 5. uncontrolled viral infections (HIV, HBV, HCV) 6. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 7. severe hypersensitivity reactions to S-1, cisplatin 8. Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication 9. Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TS-1 + cisplatin
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)
Radiation:
radiation
radiation 45Gy per 5 weeks

Locations

Country Name City State
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary pathological response rate to evaluate pathological response rate in locally advanced resectable gastric cancer 10 week
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