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Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03814759
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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
Gastric Adenocarcinoma Drug: TS-1 + cisplatin Radiation: radiation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
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 : December 12, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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




Primary Outcome Measures :
  1. pathological response rate [ Time Frame: 10 week ]
    to evaluate pathological response rate in locally advanced resectable gastric cancer



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814759


Contacts
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Contact: Hyo Song Kim 82-2-2228-8124 hyosong77@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Hyo Song Kim    82-2-2228-8124    hyosong77@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03814759     History of Changes
Other Study ID Numbers: 4-2015-0603
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Antineoplastic Agents