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Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

NCT ID: NCT03814759

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Gastric Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SP+CCRT

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

Group Type EXPERIMENTAL

TS-1 + cisplatin

Intervention Type DRUG

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

radiation

Intervention Type RADIATION

radiation 45Gy per 5 weeks

Interventions

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TS-1 + cisplatin

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

Intervention Type DRUG

radiation

radiation 45Gy per 5 weeks

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Hyo Song Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0603

Identifier Type: -

Identifier Source: org_study_id