A study to evaluate the safety and efficacy of S-1 plus cisplatin-based chemoradiotherapy after induction chemotherapy for locally advanced gastric adenocarcinoma.

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003685
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Histologically confirmed gastric cancer
2. Performance status of Eastern Cooperative Oncology Group 0 to 1.
3.Patients without prior therapy (radiotherapy, chemotherapy)
4.At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
5. Adequate normal organ and marrow function
6. A patient who understands that he or she has read and understood the written consent of the patient or their legal guardian and that they have signed the consent form and have the right to withdraw their consent at any time without penalty

Exclusion Criteria

1. Patients with distant metastases.
2. Diagnostic laparoscopic peritoneal metastases confirmed to be inoperable
3. Unregulated viral infections
: HIV(human immunodeficiency virus), B-viral hepatitis or C-viral hepatitis
4. Women with pregnancy (will) or pregnant and lactating women
5. Hypersensitivity or history of medication used
6. Patients with significant cardiovascular disease, complications or infection not medically controlled
- cerebrovascular disease within 1 year
- Heart disease: myocardial infarction within 1 year, unregulated hypertension, unstable angina, New York Heart Association class 2-4 heart failure, serious arrhythmia requiring treatment
- Severe injuries, moderate surgery, open biopsy within 28 days.
- Severe irreversible wounds, ulcers, fractures
- Wasting hemorrhagic disease without bleeding
- Recent active gastrointestinal tract infectious
7. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
8. Those taking medicines that can cause drug interactions with TS-1

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic response rate

Secondary Outcome Measures

Name	Time	Method
Disease free survival