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Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Primary Purpose

Gastric Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TS-1 + cisplatin
radiation
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SP+CCRT

Arm Description

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

Outcomes

Primary Outcome Measures

pathological response rate
to evaluate pathological response rate in locally advanced resectable gastric cancer

Secondary Outcome Measures

Full Information

First Posted
January 23, 2019
Last Updated
April 21, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03814759
Brief Title
Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma
Official Title
Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SP+CCRT
Arm Type
Experimental
Arm Description
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
Intervention Type
Drug
Intervention Name(s)
TS-1 + cisplatin
Intervention Description
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiation 45Gy per 5 weeks
Primary Outcome Measure Information:
Title
pathological response rate
Description
to evaluate pathological response rate in locally advanced resectable gastric cancer
Time Frame
10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo Song Kim
Phone
82-2-2228-8124
Email
hyosong77@yuhs.ac
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo Song Kim
Phone
82-2-2228-8124
Email
hyosong77@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

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