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Completed

NCT Number: NCT03814759

Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 20 years old
  • Histologically confirmed gastric adenocarcinoma
  • clinical stage : resectable gastric cancer
  • advanced confirmed (EGD)
  • extramural infiltration> 1 mm (CT)
  • positive serosa invasion (EUS)
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • no prior chemotherapy and radiotherapy
  • measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
  • Patients with adequate organ function
  • Signed informed consent

Exclusion criteria

  • Metastasis esophageal invasion > 3cm
  • inoperable peritoneal seeding disease determined by exploratory laparotomy
  • T4b invading the surrounding organs
  • lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node
  • uncontrolled viral infections (HIV, HBV, HCV)
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • severe hypersensitivity reactions to S-1, cisplatin
  • Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication
  • 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

Treatment and study plan

TS-1 + cisplatin

Drug

S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)

Radiation

Radiation

radiation 45Gy per 5 weeks

Primary outcomes

  1. pathological response rate

    Time frame: 10 week

    to evaluate pathological response rate in locally advanced resectable gastric cancer

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jan 24, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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