Preoperative Chemoradiotherapy for Locally Advanced Resec... | NCT03814759

Studies
Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

NCT03814759

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

102Actual

Phase

Phase 2

Conditions

Gastric Adenocarcinoma

Interventions

TS-1 + cisplatin
radiation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Jan 23, 2019

First Submission Date that Met QC Criteria

Jan 23, 2019

First Posted Date

Jan 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2024

Last Update Posted Date

Dec 27, 2024Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SP+CCRT	Experimental	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 Radiation: radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TS-1 + cisplatin	Drug	S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)	SP+CCRT

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C103828	titanium silicide
D002945	Cisplatin
D011827	Radiation

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds