Clinical trial · Interventional
Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma
Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherapy for Nasopharyngeal Carcinoma
- 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)
The purpose of this study is to compare individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation with traditional CTV in intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the efficacy and safety.
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 Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin 100mg/m² concurrent chemotherapy | Drug | — | UNRESOLVED |
| Cisplatin 80mg/m² concurrent chemotherapy | Drug | — | UNRESOLVED |
| Docetaxel and cisplatin (induction chemotherapy) | Drug | — | UNRESOLVED |
| Gemcitabine and cisplatin (induction chemotherapy) | Drug | — | UNRESOLVED |
| IMRT using individualized CTV | Radiation | — | UNRESOLVED |
| IMRT using traditional CTV | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individualized CTV
- description
- Patients receive IMRT using individualized CTV based on disease extension risk atlas and computer-aided delineation. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.
- interventionNames
- Radiation: IMRT using individualized CTV
- Drug: Gemcitabine and cisplatin (induction chemotherapy)
- Drug: Docetaxel and cisplatin (induction chemotherapy)
- Drug: Cisplatin 100mg/m² concurrent chemotherapy
- Drug: Cisplatin 80mg/m² concurrent chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Traditional CTV
- description
- Patients receive IMRT using traditional CTV. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). * Tumor staged as T1-4N0-3M0 (according to the 7th AJCC edition), based upon the following minimum diagnostic workup within 4 weeks prior to registration:(1) history/physical examination;(2)chest X-ray, PA and lateral OR chest CT OR PET/CT;(3) pre-treatment magnetic resonance imaging (MRI) of nasopharynx and neck, pre-treatment MRI must be done at Sun Yat-sen University Cancer Center;(4) sonography OR CT of upper abdoman OR PET/CT;(5) Bone scan OR PET/CT. * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Adequate bone marrow function based upon the complete blood count within 2 weeks prior to registration: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. * Adequate hepatic function within 2 weeks prior to registration: 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 within 2 weeks prior to registration: serum creatinine ≤ 133 umol/L or calculated creatinine clearance ≥ 60 ml/min. * Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study. * Patients must be informed of the investigational nature of this study and sign a written informed consent. Exclusion Criteria: * Age \> 65 or \< 18. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer outside head and neck region, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except fine needle aspiration biopsy) to primary tumor or nodes. * Hearing loss due to sensorineural deafness(except tumor induced conductive hearing loss). * 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), emotional disturbance, untreated active infectious disease, and acquired immune deficiency syndrome. * Prior allergic reaction to the study drugs involved in this protocol.
References
Publications (15)
- BACKGROUNDJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
- BACKGROUNDLai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17. PMID 20643517
- BACKGROUNDLin S, Pan J, Han L, Zhang X, Liao X, Lu JJ. Nasopharyngeal carcinoma treated with reduced-volume intensity-modulated radiation therapy: report on the 3-year outcome of a prospective series. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1071-8. doi: 10.1016/j.ijrobp.2008.12.015. Epub 2009 Apr 11. PMID 19362784
- BACKGROUNDLee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4. PMID 12007936
- BACKGROUNDKam MK, Teo PM, Chau RM, Cheung KY, Choi PH, Kwan WH, Leung SF, Zee B, Chan AT. Treatment of nasopharyngeal carcinoma with intensity-modulated radiotherapy: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1440-50. doi: 10.1016/j.ijrobp.2004.05.022. PMID 15590175
- BACKGROUNDTham IW, Hee SW, Yeo RM, Salleh PB, Lee J, Tan TW, Fong KW, Chua ET, Wee JT. Treatment of nasopharyngeal carcinoma using intensity-modulated radiotherapy-the national cancer centre singapore experience. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1481-6. doi: 10.1016/j.ijrobp.2009.01.018. Epub 2009 Apr 20. PMID 19386431
- Hunt MA, Zelefsky MJ, Wolden S, Chui CS, LoSasso T, Rosenzweig K, Chong L, Spirou SV, Fromme L, Lumley M, Amols HA, Ling CC, Leibel SA. Treatment planning and delivery of intensity-modulated radiation therapy for primary nasopharynx cancer. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):623-32. doi: 10.1016/s0360-3016(00)01389-4.