drugset / Trial / NCT02143388
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
Phase 3
Completed
180 enrolled
Zhao Chong
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabJiangxi Provincial Cancer Hospital · collabNational Cancer Centre, Singapore · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
Timeline
- Start
- 2014-03-31
- Primary completion
- 2018-07-27
- Completion
- 2022-08-05
Outcome
Met primary endpoint
paper Failure-free survival was improved with adjuvant capecitabine (3 years, 83.3% vs 72.2%; 5 years, 78.5% vs 65.9%; hazard ratio, 0.53 [95% CI, 0.30-0.94]; P = .03). PMID 36227615 ↗
Publications
- Liu Y, Yan W, Chen Y, Miao J, Zhang H, Wang J, Zhang Y, Huang X, Wang K, Qu Y, Chen X, Zhang J, Luo J, Li YX, Zhao C, Ma J, Wu R, Yi J. Treatment response-adapted risk index model for survival prediction and adjuvant chemotherapy selection in nonmetastatic nasopharyngeal carcinoma. NPJ Digit Med. 2025 Sep 1;8(1):564. doi: 10.1038/s41746-025-01918-2.
- Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Cisplatin | Other / unclassified | 100 mg/m2 | — |