Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- pathological response rate
Study Overview
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 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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
SP+CCRT
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
Intervention: TS-1 + cisplatin (Drug)
SP+CCRT
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
Intervention: radiation (Radiation)
Outcomes
Primary Outcomes
pathological response rate
Time Frame: 10 week
to evaluate pathological response rate in locally advanced resectable gastric cancer
Secondary Outcomes
No secondary outcomes reported
Investigators
Hyo Song Kim
professor
Yonsei University