Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer

This study is currently recruiting participants.
Verified December 2012 by Hebei Tumor Hospital
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital
ClinicalTrials.gov Identifier:
NCT01757366
First received: December 21, 2012
Last updated: March 30, 2014
Last verified: December 2012
  Purpose

Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.


Condition Intervention Phase
Self Efficacy
Drug: Ginsenoside Rg3 plus First-line Chemotherapy
Drug: First-line Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Hebei Tumor Hospital:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Overall Survival (OS) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental
Ginsenoside Rg3 plus First-line Chemotherapy
Drug: Ginsenoside Rg3 plus First-line Chemotherapy

Ginsenoside Rg3 20mg 2/day po,patients will receive Ginsenoside Rg3 until progression

XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression

Active Comparator: Active Comparator
First-line Chemotherapy
Drug: First-line Chemotherapy
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression

  Eligibility

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

Inclusion Criteria:

  1. Signed informed consent form
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
  3. Histologically or cytologically confirmed gastric cancer;
  4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  5. Life expectancy of at least 3 months;

Exclusion Criteria:

  1. Received any prior treatment including Ginsenoside Rg3;
  2. Active or uncontrolled infection;
  3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  4. Pregnant or lactating women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757366

Contacts
Contact: Baoen Shan 15931166600 15931166600@126.com

Locations
China, Hebei
Hebei Tumor Hospital Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Baoen Shan    13803343508    15931166600@126.com   
Principal Investigator: Wei Liu         
Sponsors and Collaborators
Hebei Tumor Hospital
Investigators
Principal Investigator: Wei Liu Hebei Tumor Hospital
  More Information

No publications provided

Responsible Party: Hebei Tumor Hospital
ClinicalTrials.gov Identifier: NCT01757366     History of Changes
Other Study ID Numbers: HBTH102
Study First Received: December 21, 2012
Last Updated: March 30, 2014
Health Authority: China: 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

ClinicalTrials.gov processed this record on April 22, 2014