Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

Official title:

Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03814759
• Other study ID #: 4-2015-0603
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2016
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2021
• Source: Yonsei University
• Contact: Hyo Song Kim
• Phone: 82-2-2228-8124
• Email: hyosong77[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• TS-1 + cisplatin
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)

Radiation:
• radiation
radiation 45Gy per 5 weeks

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological response rate	to evaluate pathological response rate in locally advanced resectable gastric cancer	10 week