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

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ClinicalTrials.gov Identifier: NCT00252161
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

November 10, 2005
November 11, 2005
September 22, 2016
November 2005
April 2015   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: during the study conduct ]
overall survival
Complete list of historical versions of study NCT00252161 on ClinicalTrials.gov Archive Site
  • progression free survival (PFS) [ Time Frame: during the study conduct ]
  • response rate [ Time Frame: during the study conduct ]
  • proportion of protocol achievement [ Time Frame: during the study conduct ]
  • proportion of curative resection [ Time Frame: during the study conduct ]
  • adverse events [ Time Frame: during the study conduct ]
  • progression free survival (PFS)
  • response rate
  • proportion of protocol achievement
  • proportion of curative resection
  • adverse events
Not Provided
Not Provided
 
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
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)
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Neoplasm
  • Procedure: Gastrectomy with more than D2 dissection
    Gastrectomy with more than D2 dissection
  • Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
    Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
  • Active Comparator: 1
    Procedure/Surgery: Gastrectomy with more than D2 dissection
    Intervention: Procedure: Gastrectomy with more than D2 dissection
  • Experimental: 2
    Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
    Intervention: Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
300
April 2015
April 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. pregnant or breast-feeding women
  3. severe mental disease
  4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  6. myocardial infarction within six disease-free months
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00252161
JCOG0501
C000000279 ( Registry Identifier: UMIN-CTR )
Yes
Not Provided
Not Provided
Haruhiko Fukuda, Japan Clinical Oncology Group
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
Japan Clinical Oncology Group
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP