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

NCT02495493 | Completed Phase 2 DMC

• 1 other identifier: 4-2013-0548
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• pathologic response rate

  12 weeks

Secondary Outcomes (1)

• overall survival

  3,6,9, 12 weeks

Study Arms (1)

Induction DCS chemotherapy

EXPERIMENTAL

1. Induction chemotherapy -- S-1 35mg/m2 bid day 1-14 * Docetaxel 30 mg/m2 day1, 8 * Cisplatin 30 mg/m2 day1, 8 2. Chemoradiotherapy : S-1 20 mg/m2 bid (Day 1-14, 21-28) cisplatin (30 mg/m2/day, Day 1,8, 21,28), Radiotherapy 45 Gy

Drug: Induction DCS chemotherapy

Interventions

Induction DCS chemotherapy DRUG

docetaxel /cisplatin/S-1 followed by chemoradiotherapy (S-1/cisplatin)

Induction DCS chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• metastatic disease
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
• 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)
• Pregnant or lactating female
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Kim HS, Koom WS, Baek SE, Kim HI, Jung M, Beom SH, Kang B, Kim H, Chang JS, Choi YY, Son T, Cheong JH, Noh SH, Kim EH, Park JC, Shin SK, Lee SK, Lee YC, Shin SJ, Chung H, Jung I, Chung HC, Lim JS, Hyung WJ, Rha SY. Phase II trial of preoperative sequential chemotherapy followed by chemoradiotherapy for high-risk gastric cancer. Radiother Oncol. 2019 Nov;140:143-149. doi: 10.1016/j.radonc.2019.06.029. Epub 2019 Jul 11.

  PMID: 31302344 DERIVED

Study Officials

• Sun Young Rha

  Severance Hosiptal, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Severance Hospital, Yonsei University Health System

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2013
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

KR (1)