Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

• Status: Completed
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhao Chong
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; First People's Hospital of Foshan; Guangzhou General Hospital of Guangzhou Military Command; Jiangxi Provincial Cancer Hospital; National Cancer Centre, Singapore
• Treatments: Capecitabine; Cisplatin

Criteria

Inclusion Criteria:

• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)

• Clinical stage III~IVb(UICC 7th)

• Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l

• Range from 18～70 years old

• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L

• ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN

• OSerum creatinine < 1.5×ULN

Exclusion Criteria:

• Central nervous system metastases

• Suitable for local treatment

• Uncontrolled seizure disorder or other serious neurologic disease

• Clinically significant cardiac or respiratory disease

• Drug or alcohol addition

• Do not have full capacity for civil acts

• Severe complication, active infection

• Concurrent immunotherapy or hormone therapy for other diseases

• Pregnancy or lactation