Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions

Study Overview
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Brief Summary
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Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.

Detailed Description
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The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.

Official Title
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The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions

Conditions
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Nasopharyngeal Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Radiation: radical radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx. Clinical stages,T1-4N0-3M1，IVc(AJCC 2010). The metastatic lesions ≤5 and metastatic organs ≤2 Karnofsky scores >70 Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function). Informed consent signed. Exclusion Criteria: Histologically conformed initial keratinizing carcinoma or others. The metastatic lesions >5 or metastatic organs >2. Any severe complications contraindicated chemotherapy or radiotherapy. History of malignant tumors. Pregnant or nursing women. History of radiotherapy or chemotherpy in head and neck regions. Patients refused the informed consent.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy. | Radiation: radical radiotherapy<br>* radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Events of death caused by any reasons | From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival | adverse event including death, recurrence and metastases. | From date of diagnosis until the date of first documented progression, assessed up to 36 months |