Clinical trial · Interventional
Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
NCT03020329CI-TRIAL-00039914unknownPhase 2ClinicalTrials.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)
1\. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Children | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fu | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel liposome | Drug | Paclitaxel Liposome | ALIAS |
| Radical radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel liposome, Cisplatin, 5-Fu,
- description
- Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
- interventionNames
- Drug: Paclitaxel liposome
- Drug: Cisplatin
- Drug: 5-fu
- Radiation: Radical radiotherapy
Primary outcomes (1)
- measure
- Complete Response (CR)
- timeFrame
- After the completion of the chemoradiotherapy treatment (up to 9 weeks)
- description
- CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition） * No evidence of distant metastasis (M0). * Age ≤ 18 years old. * Satisfactory performance status: Karnofsky scale (KPS) \> 70. * Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. * Adequate renal function: creatinine clearance ≥60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age \>18 years. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation. * History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
References
Publications (12)
- BACKGROUNDDaoud J, Ghorbal L, Siala W, Elloumi F, Ghorbel A, Frikha M. [Is there any difference in therapeutic results of nasopharyngeal carcinoma between adults and children?]. Cancer Radiother. 2013 Dec;17(8):763-7. doi: 10.1016/j.canrad.2013.06.046. Epub 2013 Nov 20. French. PMID 24269016
- BACKGROUNDYan Z, Xia L, Huang Y, Chen P, Jiang L, Zhang B. Nasopharyngeal carcinoma in children and adolescents in an endemic area: a report of 185 cases. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1454-60. doi: 10.1016/j.ijporl.2013.06.005. Epub 2013 Jul 3. PMID 23830224
- BACKGROUNDLiao WW, Tang SQ, Liu Y, Feng C. [Treatment of nasopharyngeal carcinoma in children]. Zhongguo Dang Dai Er Ke Za Zhi. 2013 Apr;15(4):273-6. Chinese. PMID 23607949
- BACKGROUNDHu S, Xu X, Xu J, Xu Q, Liu S. Prognostic factors and long-term outcomes of nasopharyngeal carcinoma in children and adolescents. Pediatr Blood Cancer. 2013 Jul;60(7):1122-7. doi: 10.1002/pbc.24458. Epub 2013 Jan 9. PMID 23303571
- BACKGROUNDCheuk DK, Billups CA, Martin MG, Roland CR, Ribeiro RC, Krasin MJ, Rodriguez-Galindo C. Prognostic factors and long-term outcomes of childhood nasopharyngeal carcinoma. Cancer. 2011 Jan 1;117(1):197-206. doi: 10.1002/cncr.25376. Epub 2010 Aug 24. PMID 20737561
- BACKGROUNDBuehrlen M, Zwaan CM, Granzen B, Lassay L, Deutz P, Vorwerk P, Staatz G, Gademann G, Christiansen H, Oldenburger F, Tamm M, Mertens R. Multimodal treatment, including interferon beta, of nasopharyngeal carcinoma in children and young adults: preliminary results from the prospective, multicenter study NPC-2003-GPOH/DCOG. Cancer. 2012 Oct 1;118(19):4892-900. doi: 10.1002/cncr.27395. Epub 2012 Feb 22. PMID 22359313
- BACKGROUNDShen C, Gao Y, Xu T, Wang X, Ying H, Hu C. Carcinoma of the nasopharynx in young patients: a single institution experience. Clin Oncol (R Coll Radiol). 2009 Oct;21(8):617-22. doi: 10.1016/j.clon.2009.07.005. Epub 2009 Aug 5.