Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 3, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 19, 2013
September 1, 2013
3.3 years
August 3, 2010
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
progression-free survival: the time between tumor regression to progression
1 year progression-free survival
Secondary Outcomes (2)
overall responses
1 month after treatment
overall survival time
1 month after treatment
Study Arms (1)
nimotuzumab
EXPERIMENTALCombination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.
Interventions
200 milligram (mg) of nimotuzumab per week during radiation period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- Extensive distant metastases
- Pregnancy or in lactation
- Allergic to 5-Fluorouracil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jing jin, M.D.
Chinese Acedemy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice chair of radiation department, Chinese Academy of Medical Sciences
Study Record Dates
First Submitted
August 3, 2010
First Posted
August 12, 2010
Study Start
May 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 19, 2013
Record last verified: 2013-09