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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-05-31

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.

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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maintenance capecitabine

maintenance capecitabine plus best supportive care(BSC)

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

Best supportive care (BSC)

Intervention Type OTHER

Best supportive care and following-up every 6-8 weeks

best supportive care

Best supportive care and following-up every 6-8 weeks

Group Type OTHER

Best supportive care (BSC)

Intervention Type OTHER

Best supportive care and following-up every 6-8 weeks

Interventions

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capecitabine

capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

Intervention Type DRUG

Best supportive care (BSC)

Best supportive care and following-up every 6-8 weeks

Intervention Type OTHER

Other Intervention Names

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Xeloda

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No