A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer - Full Text View

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00252161

Purpose

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.

Condition	Intervention	Phase
Gastric Neoplasm	Procedure: Gastrectomy with more than D2 dissection Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy	Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

overall survival

Secondary Outcome Measures:

progression free survival (PFS)
response rate
proportion of protocol achievement
proportion of curative resection
adverse events

Estimated Enrollment:	316
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Procedure/Surgery: Gastrectomy with more than D2 dissection	Procedure: Gastrectomy with more than D2 dissection
2: Experimental Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy	Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Detailed Description:

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically proven adenocarcinoma of stomach
Borrmann type 4 or large (>=8 cm) type 3
no evidence of distant metastasis including liver(M0)
no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
no involvement of the esophagus with > 3cm
an age of 20-75 years
an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
no prior chemotherapy, radiotherapy for any malignancy
no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
no breeding from primary tumor or gastrointestinal stenosis
sufficient oral intake
adequate organ function
written informed consent

Exclusion Criteria:

synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
pregnant or breast-feeding women
severe mental disease
systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
myocardial infarction within six disease-free months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252161

Contacts

Contact: Yoshiaki Iwasaki, MD, PhD	81-3-3823-2101	JCOG_sir@ml.jcog.jp
Contact: Kuniyoshi Arai, MD, PhD	81-3-3823-2101	JCOG_sir@ml.jcog.jp

Show 35 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Mitsuru Sasako, MD, PhD

Hyogo College of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Japan Clinical Oncology Group ( Mitsuru Sasako, MD, PhD )
Study ID Numbers:	JCOG0501, C000000279
Study First Received:	November 10, 2005
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00252161
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

Neoadjuvant Therapy
Stomach Neoplasms
Cisplatin
S-1(combination)

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009