Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02012062

Enrollment

160

Registered

2013-12-16

Start date

2012-07-31

Completion date

2017-08-31

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab

Brief summary

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.

Detailed description

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

Interventions

DRUGConcurrent nimotuzumab during radiotherapy

RADIATIONRadical radiotherapy

DRUGTPF neoadjuvant chemotherapy

DRUGConcurrent chemotherapy with cisplatin during radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)	From Day 1 to Day 90 of radiotherapy

Secondary

Measure	Time frame
PFS	3 years
OS	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026