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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Gastric Neoplasm

Intervention / Treatment
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* Procedure: Gastrectomy with more than D2 dissection
* Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: Gastrectomy with more than D2 dissection | Procedure: Gastrectomy with more than D2 dissection<br>* Gastrectomy with more than D2 dissection<br>|
| Experimental: 2<br>Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy | Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy<br>* Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) |  | during the study conduct | 
| response rate |  | during the study conduct | 
| proportion of protocol achievement |  | during the study conduct | 
| proportion of curative resection |  | during the study conduct | 
| adverse events |  | during the study conduct | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)