Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.

Detailed Description
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Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.

Official Title
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Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: capecitabine
* Other: Best supportive care (BSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Firstly diagnosed metastatic nasopharyngeal carcinoma patients Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectation at least 12 weeks No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy With at least one measurable lesion Enough blood test Signed informed consent Exclusion Criteria: Sever heart disease HIV infection Sever infection Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks Allogeneic organ transplantation Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years Pregnancy or breast feeding Difficulty in swallowing Received other test drugs

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: maintenance capecitabine<br>maintenance capecitabine plus best supportive care(BSC) | Drug: capecitabine<br>* capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.<br>* Other names: Xeloda;Other: Best supportive care (BSC)<br>* Best supportive care and following-up every 6-8 weeks<br>|
| Other: best supportive care<br>Best supportive care and following-up every 6-8 weeks | Other: Best supportive care (BSC)<br>* Best supportive care and following-up every 6-8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | the time from randomization to the progression of disease | up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the time from randomization to death | up to 6 years | 
| duration of response | the time from the date of the first cycle of chemotherapy to the progression of disease | up to 6 years | 
| objective response rate | CR, PR and SD rate | up to 6 years | 
| adverse effects | chemotherapy side effects | up to 6 years | 
| quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care | evaluate with FACT-H&N every 3 months after randomiztion | up to 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, metastasis, capecitabine