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Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

This study is currently recruiting participants.
Verified May 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01180166
First received: August 3, 2010
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.


Condition Intervention Phase
Gastric Cancer
Concurrent Chemoradiotherapy
 Drug: nimotuzumab
 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: Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 1 year progression-free survival ] [ Designated as safety issue: Yes ]
    progression-free survival: the time between tumor regression to progression


Secondary Outcome Measures:
  • overall responses [ Time Frame: 1 month after treatment ] [ Designated as safety issue: Yes ]
    the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system

  • overall survival time [ Time Frame: 1 month after treatment ] [ Designated as safety issue: Yes ]
    median overall survival time


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nimotuzumab
Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.
 Drug: nimotuzumab
200 milligram (mg) of nimotuzumab per week during radiation period
Other Name: Nimotuzumab injection, Tai Xin-sheng

Detailed Description:

There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

  Eligibility

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

Inclusion Criteria:

  • 18-75 years old, male or female
  • Gastric cancer with measurable lesions, and the diameter is at least 1 cm
  • Karnofsky score: at least 70
  • Estimated survival: at least 6 months
  • No prior target therapy or radiotherapy
  • No severe hypertension, cardiac disease, or diabetes mellitus
  • Normal blood routine and chemical tests
  • Signed consent

Exclusion Criteria:

  • Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
  • Extensive distant metastases
  • Pregnancy or in lactation
  • Allergic to 5-Fluorouracil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180166

Contacts
Contact: Ningning Lu, Doctor +86 01087788280 ykyzlyy@hotmail.com
Contact: Yexiong Li, Doctor +86 01087788890 yexiong3@yahoo.com.cn

Locations
China, Beijing
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Ningning Lu, Doctor     +86 01087788280     ykyzlyy@hotmail.com    
Contact: Yexiong Li, Doctor     +86 01087788860     yexiong3@yahoo.com.cn    
Principal Investigator: Yexiong Li, Doctor            
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: jing jin, M.D. Chinese Acedemy of Medical Sciences
  More Information

No publications provided

Responsible Party: Jing Jin, M.D., vice chair of radiation department, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01180166     History of Changes
Other Study ID Numbers: CH-GI-010
Study First Received: August 3, 2010
Last Updated: May 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Gastric cancer
concurrent chemoradiotherapy
target therapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013