Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase

Unknown

Phase 3

Conditions

Nasopharyngeal Carcinoma

Treatments

Radiation: Loco-regional Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02111460

SYSUCC5010

Details and patient eligibility

About

This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.

Enrollment

126 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patients with initial untreated metastatic nasopharyngeal carcinoma
Histologic diagnosis of nasopharyngeal carcinoma
T1-4N0-3M1,IVC(according to the 7th AJCC edition)
Aged between 18 and 65 years
KPS≥70
The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
Voluntary to participate and sign informed consent document

Exclusion criteria

The patients suffered from serious neurologic disease
Clinically significant cardiac, heart function less than or equal to 3 level
Clinically significant respiratory disease,lung function less than or equal to 3 level
Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L
Abnormal liver function: total bilirubin or ALT or AST>2×ULN
Abnormal renal function:serum creatinine>1.5×ULN
Pregnant or lactating women
The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu