Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
NCT ID: NCT02012062
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2012-07-31
2017-08-31
Brief Summary
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Detailed Description
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Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
\- Arm Cisplatin:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
\- Arm nimotuzumab:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm Cisplatin
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
TPF neoadjuvant chemotherapy
Concurrent chemotherapy with cisplatin during radiotherapy
Radical radiotherapy
Arm Nimotuzumab
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
TPF neoadjuvant chemotherapy
Concurrent nimotuzumab during radiotherapy
Radical radiotherapy
Interventions
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TPF neoadjuvant chemotherapy
Concurrent chemotherapy with cisplatin during radiotherapy
Concurrent nimotuzumab during radiotherapy
Radical radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Stage III and IVA/B NPC patients
* KPS \>70
* Age between 18-70
* AGC \> 2000, platelets \> 100,000, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min
Exclusion Criteria
* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
* Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
* Prior radiation treatment to the head and neck or any prior chemotherapy
18 Years
70 Years
ALL
No
Sponsors
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Fujian Province Tumor Hospital
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Fudan University
OTHER
Responsible Party
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Lin Kong
Dr.
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Other Identifiers
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NPC-IMRT-N
Identifier Type: -
Identifier Source: org_study_id
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