Clinical trial · Interventional
Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity
NCT02111460CI-TRIAL-00045019unknownPhase 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 a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic 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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loco-regional Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Systemic Chemotherapy Combined with Loco-regional Radiotherapy
- interventionNames
- Radiation: Loco-regional Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Chemotherapy alone without Loco-regional Radiotherapy
- interventionNames
- Radiation: Loco-regional Radiotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * The patients with initial untreated metastatic nasopharyngeal carcinoma * Histologic diagnosis of nasopharyngeal carcinoma * T1-4N0-3M1,IVC(according to the 7th AJCC edition) * Aged between 18 and 65 years * KPS≥70 * The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu * Voluntary to participate and sign informed consent document Exclusion Criteria: * The patients suffered from serious neurologic disease * Clinically significant cardiac, heart function less than or equal to 3 level * Clinically significant respiratory disease,lung function less than or equal to 3 level * Blood routine examination: WBC\<3×109/L, Hemoglobin\<90g/L, platelet count\<75×109/L * Abnormal liver function: total bilirubin or ALT or AST\>2×ULN * Abnormal renal function:serum creatinine\>1.5×ULN * Pregnant or lactating women * The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
References
Publications (1)
- DERIVEDYou R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808. PMID 32701129