Clinical trial · Interventional
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
NCT02143388CI-TRIAL-00060620completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Advanced High Risk Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT combine with cisplatin concurrent chemotherapy | Drug | — | UNRESOLVED |
| IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concurrent chemoradiation + adjuvant chemotherapy
- description
- IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- interventionNames
- Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiation
- description
- IMRT combine with cisplatin concurrent chemotherapy
- interventionNames
- Drug: IMRT combine with cisplatin concurrent chemotherapy
Primary outcomes (1)
- measure
- Failure free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III) * Clinical stage III\~IVb(UICC 7th) * Meet at least one factor below :1 primary tumor SUVmax\>10 in 18F-FDG PET/CT;2 primary tumor volume\>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter\>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA\>2×10E4 copy/l * Range from 18～70 years old * WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L * ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN * OSerum creatinine \< 1.5×ULN Exclusion Criteria: * Central nervous system metastases * Suitable for local treatment * Uncontrolled seizure disorder or other serious neurologic disease * Clinically significant cardiac or respiratory disease * Drug or alcohol addition * Do not have full capacity for civil acts * Severe complication, active infection * Concurrent immunotherapy or hormone therapy for other diseases * Pregnancy or lactation
References
Publications (2)
- DERIVEDLiu 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. PMID 40890288
- DERIVEDMiao 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. PMID 36227615