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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT01180166
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
40
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
May 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Nimotuzumab injection, Tai Xin-sheng

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [1 year progression-free survival]

      progression-free survival: the time between tumor regression to progression

    Secondary Outcome Measures

    1. overall responses [1 month after treatment]

      the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system

    2. overall survival time [1 month after treatment]

      median overall survival time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: jing jin, M.D., Chinese Acedemy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • CH-GI-010
    First Posted:
    Aug 12, 2010
    Last Update Posted:
    Sep 19, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Jing Jin, M.D., vice chair of radiation department, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences
    Gastric cancer
    concurrent chemoradiotherapy
    target therapy
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Nimotuzumab

    Study Results

    No Results Posted as of Sep 19, 2013