Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Fujian Province Tumor Hospital; The First Affiliated Hospital of Xiamen University
• Treatments: Cisplatin; Nimotuzumab

Criteria

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