Overview

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