Concurrent Chemoradiotherapy, Gastric Cancer
Conditions
Keywords
Gastric cancer, concurrent chemoradiotherapy, target therapy
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.
Interventions
DRUGnimotuzumab
200 milligram (mg) of nimotuzumab per week during radiation period
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 1 year progression-free survival | progression-free survival: the time between tumor regression to progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| overall survival time | 1 month after treatment | median overall survival time |
Countries
China
Contacts
Primary ContactNingning Lu, Doctor
Backup ContactJing Jin, M.D.
Outcome results
None listed