Clinical trial NCT03814759: Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma
Official title: Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pathological response rate
timeFrame: 10 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References: