drugset / Trial / NCT02944708
Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Phase 3
Unknown
384 enrolled
Shanghai Proton and Heavy Ion Center
Cancer Hospital of Guangxi Medical University · collabEye & ENT Hospital of Fudan University · collabFirst Affiliated Hospital of Fujian Medical University · collabFudan University · collabJiangxi Provincial Cancer Hospital · collabNational Cancer Centre, Singapore · collabPeking University Cancer Hospital & Institute · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabTaichung Veterans General Hospital · collabThe First Affiliated Hospital of Xiamen University · collabTongji Hospital · collabWest China Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
Timeline
- Start
- 2015-10
- Primary completion
- 2018-10
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Maintenance chemotherapy 1 | Unknown | 40 mg | Oral |
| Subject | tegafur-uracil | Small molecule | 100 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |