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

Primary Purpose

Gastric Cancer, Concurrent Chemoradiotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nimotuzumab
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, concurrent chemoradiotherapy, target therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nimotuzumab

Arm Description

Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2010
Last Updated
September 17, 2013
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01180166
Brief Title
Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
Official Title
Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Concurrent Chemoradiotherapy
Keywords
Gastric cancer, concurrent chemoradiotherapy, target therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nimotuzumab
Arm Type
Experimental
Arm Description
Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Other Intervention Name(s)
Nimotuzumab injection, Tai Xin-sheng
Intervention Description
200 milligram (mg) of nimotuzumab per week during radiation period
Primary Outcome Measure Information:
Title
progression-free survival
Description
progression-free survival: the time between tumor regression to progression
Time Frame
1 year progression-free survival
Secondary Outcome Measure Information:
Title
overall responses
Description
the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system
Time Frame
1 month after treatment
Title
overall survival time
Description
median overall survival time
Time Frame
1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ningning Lu, Doctor
Phone
+86 01087788280
Email
ykyzlyy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, M.D.
Phone
+86 0108778280
Email
jingjin1025@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jing jin, M.D.
Organizational Affiliation
Chinese Acedemy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningning Lu, Doctor
Phone
+86 01087788280
Email
ykyzlyy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jing Jin, M.D.
Phone
+86 01087788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name & Degree
Jing Jin, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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