Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Phase 3CompletedNCT02012062

Fudan University160 enrolled

Overview

The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.

Scheme: 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Nasopharyngeal Carcinoma

Interventions

TPF neoadjuvant chemotherapyDRUG

Concurrent chemotherapy with cisplatin during radiotherapyDRUG

Concurrent nimotuzumab during radiotherapyDRUG

Radical radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx. * 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: * Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma. * 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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)

Time frame: From Day 1 to Day 90 of radiotherapy

Secondary Outcomes

PFS

Time frame: 3 years

Data from ClinicalTrials.gov

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