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

Gastric Cancer Clinical Trial

Official title:

Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01180166
• Other study ID #: CH-GI-010
• Status: Recruiting
• Phase: Phase 2
• First received: August 3, 2010
• Last updated: September 17, 2013
• Start date: May 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Ningning Lu, Doctor
• Phone: +86 01087788280
• Email: ykyzlyy[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Concurrent Chemoradiotherapy
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• nimotuzumab
200 milligram (mg) of nimotuzumab per week during radiation period

Locations

Country	Name	City	State
China	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	progression-free survival: the time between tumor regression to progression	1 year progression-free survival	Yes
Secondary	overall responses	the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system	1 month after treatment	Yes
Secondary	overall survival time	median overall survival time	1 month after treatment	Yes