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Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01756183
Recruitment Status : Unknown
Verified December 2012 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 25, 2012
Last Update Posted Date December 25, 2012
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
radical resection rate [ Time Frame: 3 months ]
radical resection rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
  • Adverse Events [ Time Frame: 6 months ]
    Number and degree of Adverse Events
  • reaction rate [ Time Frame: 2 months ]
    the reaction rate of chemotherapy
  • overall survival time [ Time Frame: 3 years ]
    the overall survival time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
Official Title  ICMJE Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer
Brief Summary Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
Detailed Description To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgically-Created Resection Cavity
  • Drug Safety
Intervention  ICMJE Drug: S-1 + Paclitaxel Chemotherapy

Dose of S-1: 60mg bid,Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.

Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1

Study Arms  ICMJE Experimental: S-1 + Paclitaxel Chemotherapy

S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.

Paclitaxel: 150 mg/m2, iv, 3h, at D1

Intervention: Drug: S-1 + Paclitaxel Chemotherapy
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)

  • Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
  • Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • ECOG (Eastern Cooperative Oncology Group) : 0~2
  • Age: 18~75 years old
  • Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
  • Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  • Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
  • Not participating in other study projects before and during the treatment
  • Signed the Informed Consent Form

Exclusion Criteria:

  • Not conforming to above inclusion criteria
  • Distal metastasis to lung, brain and bone (except the liver)
  • Ever operation on the stomach
  • Operation intolerance due to other systemic basic diseases
  • Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
  • Allergy to the drugs in this protocol
  • Pregnant or lactating women
  • Women at childbearing age and of pregnancy desire during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756183
Other Study ID Numbers  ICMJE SPECIAL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: xiangdong Cheng, MD Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date December 2012

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