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Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03814759
Collaborator
(none)
102
Enrollment
1
Location
1
Arm
67.6
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TS-1 + cisplatin
  • Radiation: radiation
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial
Actual Study Start Date :
Dec 12, 2016
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pathological response rate [10 week]

    to evaluate pathological response rate in locally advanced resectable gastric cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. Eastern Cooperative Oncology Group performance status 0 or 1

  2. no prior chemotherapy and radiotherapy

  3. measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria

  4. Patients with adequate organ function

  5. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyo Song Kim, professor, Yonsei University
ClinicalTrials.gov Identifier:
NCT03814759
Other Study ID Numbers:
  • 4-2015-0603
First Posted:
Jan 24, 2019
Last Update Posted:
Apr 22, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma
Cisplatin

Study Results

No Results Posted as of Apr 22, 2021