S-1, Cisplatin-based Chemoradiotherapy, Induction Chemotherapy, Locally Advanced Gastric Adenocarcinoma

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve efficacy, but less toxicity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histologically confirmed gastric cancer

• Clinical stage : - Borrmann type IV

• Large Borrmann type III (>8cm)

• Locally extensive nodal disease

• No evidence of metastasis

• Patients with tumor lesions which can be easily obtained fresh tumor tissue through repeated biopsies.

• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

• Age≥ 20 years old.

• Performance status of Eastern Cooperative Oncology Group 0 to 2.

• Adequate organ function.

Exclusion Criteria:

1. metastatic disease

2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

3. Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)

4. Pregnant or lactating female

5. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study