Clinical trial · Interventional
Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)
Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)
NCT01326559CI-TRIAL-00029099completedPhase 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)
Study Objective: Primary 1\. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT). Secondary 1. To determine the overall response rate. 2. To determine the locoregional and distant control rate 3. To determine the progression-free survival (PFS) 4. To determine the overall survival (OS) 5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.
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 |
|---|---|---|---|
| Docetaxel, Cisplatin, 5-FU and Cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental 1
- description
- Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16
- interventionNames
- Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 5 years
- description
- Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.
Secondary outcomes (4)
- measure
- Overall response rate
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: * Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy * Age \> 18 to \< 70 years * Performance status: \< 1 by ECOG System (Appendix I) * Adequate bone marrow \& renal function * Patients having Bilirubin =\< 1.5 x ULN, ASAT \& ALST=\< 1.5 x ULN, Serum creatinine=\< 1.25 x ULN and / or Creatinine clearance \>= 60ml/min * Patients having WBC \>= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets \>= 100 x10e9/L,Hemoglobin \>=10g/dL * Signed written informed consent * Patients must have at least one measurable lesion Exclusion Criteria: * Use of investigational agent within the past 28 days * Pre-treatment with an anti-EGFR drug * Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months * History of severe pulmonary diseases * Active infection or other systemic disease under poor control * Uncontrolled chronic neuropathy * Know grade 3 or 4 allergic reaction to any of the components of the treatment * Estimated life expectancy is less than 3 months * Pregnancy or breast feeding
References
Publications (14)
- BACKGROUNDFu KK, Newman H, Phillips TL. Treatment of locally recurrent carcinoma of the nasopharynx. Radiology. 1975 Nov;117(2):425-31. doi: 10.1148/117.2.425. PMID 170644
- BACKGROUNDPryzant RM, Wendt CD, Delclos L, Peters LJ. Re-treatment of nasopharyngeal carcinoma in 53 patients. Int J Radiat Oncol Biol Phys. 1992;22(5):941-7. doi: 10.1016/0360-3016(92)90792-g. PMID 1555986
- BACKGROUNDWang CC. Re-irradiation of recurrent nasopharyngeal carcinoma--treatment techniques and results. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):953-6. doi: 10.1016/0360-3016(87)90030-7. PMID 3597157
- BACKGROUNDTeo PM, Kwan WH, Chan AT, Lee WY, King WW, Mok CO. How successful is high-dose (> or = 60 Gy) reirradiation using mainly external beams in salvaging local failures of nasopharyngeal carcinoma? Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):897-913. doi: 10.1016/s0360-3016(97)00854-7. PMID 9531376
- BACKGROUNDLeung TW, Tung SY, Sze WK, Sze WM, Wong VY, Wong CS, O SK. Salvage radiation therapy for locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1331-8. doi: 10.1016/s0360-3016(00)00776-8. PMID 11121630
- BACKGROUNDPoon D, Yap SP, Wong ZW, Cheung YB, Leong SS, Wee J, Tan T, Fong KW, Chua ET, Tan EH. Concurrent chemoradiotherapy in locoregionally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1312-8. doi: 10.1016/j.ijrobp.2004.01.037. PMID 15275714
- BACKGROUNDYan JH, Hu YH, Gu XZ. Radiation therapy of recurrent nasopharyngeal carcinoma. Report on 219 patients. Acta Radiol Oncol. 1983;22(1):23-8. doi: 10.3109/02841868309134335. PMID 6305129
- BACKGROUNDLu TX, Mai WY, Teh BS, Zhao C, Han F, Huang Y, Deng XW, Lu LX, Huang SM, Zeng ZF, Lin CG, Lu HH, Chiu JK, Carpenter LS, Grant WH 3rd, Woo SY, Cui NJ, Butler EB. Initial experience using intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):682-7. doi: 10.1016/S0360-3016(03)01508-6.