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A Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer

NCT01269255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-06-04

No results posted yet for this study

Summary

A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP) as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy was effectively used in esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve survival and increase pathologic complete response in patients with gastric cancer. Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced tumors.

Conditions

Interventions

DRUG

TS-1 with Cisplatin

SP CCRT(= TS-1 with Cisplatin concurrent radiation therapy) * Step 1: Chemotherapy; TS-1/CDDP #2 cycles * Step 2: Chemoradiotherapy; CCRT with weekly TS-1/CDDP * Step 3: Surgery therapy

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269255 on ClinicalTrials.gov