Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Gastric Adenocarcinoma

Treatments: Drug: TS-1 + cisplatin; Radiation: radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03814759

4-2015-0603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

SP+CCRT

Experimental group

Description:

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

Treatment:

Radiation: radiation

Drug: TS-1 + cisplatin