Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Phase 2

Completed

• Conditions: Gastric Adenocarcinoma
• Interventions: Drug: TS-1 + cisplatin; Radiation: radiation

• Registration Number: NCT03814759
• Lead Sponsor: Yonsei University

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 Timeline

• Study Start: 2016-12-12
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Status Verified: 2021-04
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-31
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP+CCRT	TS-1 + cisplatin	S-1 20mg/m2, bid (D1\~14, D22\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
SP+CCRT	radiation	S-1 20mg/m2, bid (D1\~14, D22\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks

Primary Outcome Measures

Name	Time	Method
pathological response rate	10 week	to evaluate pathological response rate in locally advanced resectable gastric cancer

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of