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

Phase 3

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: capecitabine; Other: Best supportive care (BSC)

• Registration Number: NCT02460419
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-23
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maintenance capecitabine	Best supportive care (BSC)	maintenance capecitabine plus best supportive care(BSC)
best supportive care	Best supportive care (BSC)	Best supportive care and following-up every 6-8 weeks
maintenance capecitabine	capecitabine	maintenance capecitabine plus best supportive care(BSC)

Primary Outcome Measures

Name	Time	Method
progression-free survival	up to 6 years	the time from randomization to the progression of disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China