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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 11, 2005
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE November 2005
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
overall survival [ Time Frame: during the study conduct ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
overall survival
Change History Complete list of historical versions of study NCT00252161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
  • progression free survival (PFS)
  • response rate
  • proportion of protocol achievement
  • proportion of curative resection
  • adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Official Title  ICMJE 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)
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2008)
316
Original Enrollment  ICMJE
 (submitted: November 10, 2005)
300
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00252161
Other Study ID Numbers  ICMJE JCOG0501
C000000279 ( Registry Identifier: UMIN-CTR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haruhiko Fukuda, Japan Clinical Oncology Group
Study Sponsor  ICMJE Haruhiko Fukuda
Collaborators  ICMJE Ministry of Health, Labour and Welfare, Japan
Investigators  ICMJE
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
PRS Account Japan Clinical Oncology Group
Verification Date September 2016

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