Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
| Registry | NCT02460419 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 104 (Actual) |
| Sponsor | Sun Yat-sen University (Other); collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College |
| Conditions | Nasopharyngeal Carcinoma |
| Interventions | capecitabine, Best supportive care (BSC) (Drug, other) |
| Dates | start 2015-04-01, primary completion 2020-05-01, completion 2020-05-01, first posted 2015-06-02, last updated 2022-10-28 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| maintenance capecitabine | Experimental | Drug: capecitabine; Other: Best supportive care (BSC) | maintenance capecitabine plus best supportive care(BSC) |
| best supportive care | Other | Other: Best supportive care (BSC) | Best supportive care and following-up every 6-8 weeks |
Sex: All, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| SunYat-senU | Guangzhou, Guangdong | China |