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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014