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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: capecitabine; Other: Best supportive care (BSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02460419

2015029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

maintenance capecitabine

Experimental group

Description:

maintenance capecitabine plus best supportive care(BSC)

Treatment:

Other: Best supportive care (BSC)

Drug: capecitabine

best supportive care

Other group

Description:

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

Treatment:

Other: Best supportive care (BSC)