Nasopharyngeal Carcinoma
Conditions
Keywords
Initially, Untreated, Distant metastatic
Brief summary
This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.
Interventions
RADIATIONLoco-regional Radiotherapy
with or without Loco-regional Radiotherapy
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival | 2 years | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. |
| Complete Response (CR) | after the completion of the chemoradiotherapy treatment (up to 9 weeks) | CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only. |
Countries
China
Outcome results
None listed