Status:
COMPLETED
Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma
Lead Sponsor:
Yonsei University
Conditions:
Gastric Adenocarcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 excludi...
Detailed Description
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 excludi...
Eligibility Criteria
Inclusion
- Age ≥ 20 years old
- Histologically confirmed gastric adenocarcinoma
- clinical stage : resectable gastric cancer
- advanced confirmed (EGD)
- extramural infiltration\> 1 mm (CT)
- positive serosa invasion (EUS)
- Eastern Cooperative Oncology Group performance status 0 or 1
- no prior chemotherapy and radiotherapy
- measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
- Patients with adequate organ function
- Signed informed consent
Exclusion
- Metastasis esophageal invasion \> 3cm
- inoperable peritoneal seeding disease determined by exploratory laparotomy
- T4b invading the surrounding organs
- lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node
- uncontrolled viral infections (HIV, HBV, HCV)
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- severe hypersensitivity reactions to S-1, cisplatin
- Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication
- 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
Key Trial Info
Start Date :
December 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03814759
Start Date
December 12 2016
End Date
July 31 2022
Last Update
December 27 2024
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722