Clinical trial · Interventional
Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
NCT01536223CI-TRIAL-00009637ESNCCTunknownPhase 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)
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
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 |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF (cisplatin and 5-fluorouracil) group | Drug | — | UNRESOLVED |
| TPF (docetaxel plus cisplatin and 5-fluorouracil) group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PF group
- description
- the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
- interventionNames
- Drug: PF (cisplatin and 5-fluorouracil) group
- type
- EXPERIMENTAL
- label
- TPF group
- description
- TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
- interventionNames
- Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group
Primary outcomes (1)
- measure
- 3-year progress free survival(PFS)
- timeFrame
- 3 years after the inception assignment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system) 3. No evidence of distant metastasis(M0) 4. Performance status:KPS\>70 5. With normal liver function test(ALT, AST\<1.5ULN) 6. Renal:creatinine clearance \>60ml/min 7. Without hematopathy,marrow:WBC\>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L. 8. With controled blood glucose for diabetes patients 9. Written informed consent Exclusion Criteria: 1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age\>70 or \<18 3. With a history of renal disease 4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0 5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume) 6. Patient is pregnant or lactating . 7. Peripheral neuropathy 8. Emotional disturbance
References
Publications (1)
- DERIVEDJin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20. PMID 30797141