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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Affiliated Cancer Hospital of Shantou University Medical College; Affiliated Tumor Hospital of Guangzhou Medical University; Cancer Hospital of Shantou University
• Treatments: Capecitabine

Criteria

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