Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

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

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 Overview

• Status: Completed
• Conditions: Gastric Adenocarcinoma
• Intervention / Treatment: Drug: TS-1 + cisplatin; Radiation: radiation

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP+CCRT; S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological response rate	to evaluate pathological response rate in locally advanced resectable gastric cancer	10 week

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: 4-2015-0603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No