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

This study is currently recruiting participants.
Verified December 2012 by Zhejiang Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01756183
First received: November 29, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer


Condition Intervention Phase
Surgically-Created Resection Cavity
Drug Safety
 Drug: S-1 + Paclitaxel Chemotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • radical resection rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    radical resection rate


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number and degree of Adverse Events

  • reaction rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    the reaction rate of chemotherapy

  • overall survival time [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    the overall survival time


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756183

Contacts
Contact: xiangdong Cheng, MD +86 571 88122516 abdsurg@hotmail.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: xiangdong Cheng, MD     +86 571 88122516 ext -     abdsurg@hotmail.com    
Principal Investigator: xiangdong Cheng, MD            
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: xiangdong Cheng, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01756183     History of Changes
Other Study ID Numbers: SPECIAL
Study First Received: November 29, 2012
Last Updated: December 19, 2012
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013