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

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

Official Title
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Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: Loco-regional Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>Systemic Chemotherapy Combined with Loco-regional Radiotherapy | Radiation: Loco-regional Radiotherapy<br>* with or without Loco-regional Radiotherapy<br>|
| Active Comparator: Chemotherapy<br>Chemotherapy alone without Loco-regional Radiotherapy | Radiation: Loco-regional Radiotherapy<br>* with or without Loco-regional Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. | 2 years | 
| Complete Response (CR) | 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. | after the completion of the chemoradiotherapy treatment (up to 9 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Initially, Untreated, Distant metastatic