Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity
NCT ID: NCT07072000
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2025-08-01
2032-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Reduced delineation arm
reduced CTV delineation
The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
Standard delineation arm
standard CTV delineation
The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
Interventions
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standard CTV delineation
The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
reduced CTV delineation
The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
Eligibility Criteria
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Inclusion Criteria
2. Stage I-III disease (AJCC 9th edition).
3. Tumor extends to nasal cavity (including nasal septum).
4. No distant metastasis (M0).
5. Age 18-70 years.
6. Male or non-pregnant female.
7. Scheduled for radiotherapy.
8. ECOG performance status 0-1 .
9. Adequate bone marrow function: white blood cells \>4×10⁹/L, hemoglobin \>90 g/L, platelets \>100×10⁹/L.
10. Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min.
11. Written informed consent obtained.
Exclusion Criteria
2. Age \<18 or \>70 years.
3. Recurrent disease or distant metastasis.
4. No tumor extension into the nasal cavity (including the nasal septum).
5. Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
6. Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated).
7. Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).
8. Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures).
9. Severe coexisting illness.
18 Years
70 Years
ALL
No
Sponsors
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First People's Hospital of Foshan
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
The Wuzhou Red Cross Hospital
UNKNOWN
The Fourth Affiliated Hospital of Guangxi Medical University
UNKNOWN
Zhongshan City People 's Hospital
UNKNOWN
Hai-Qiang Mai,MD,PhD
OTHER
Responsible Party
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Hai-Qiang Mai,MD,PhD
Professor
Locations
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First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhangjiang, Guangdong, China
The Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Ying Lu
Role: primary
References
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Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.
Sanford NN, Lau J, Lam MB, Juliano AF, Adams JA, Goldberg SI, Lu HM, Lu YC, Liebsch NJ, Curtin HD, Chan AW. Individualization of Clinical Target Volume Delineation Based on Stepwise Spread of Nasopharyngeal Carcinoma: Outcome of More Than a Decade of Clinical Experience. Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):654-668. doi: 10.1016/j.ijrobp.2018.10.006. Epub 2018 Oct 15.
Lin SJ, Guo QJ, Liu Q, Ng WT, Ahn YC, AlHussain H, Chan AW, Chow J, Chua MLK, Corry J, Han F, Gregoire V, Harrington KJ, Hu CS, Jensen K, Langendijk JA, Le QT, Lee NY, Lee V, Lin JC, Ma J, Mendenhall WM, O'Sullivan B, Ozyar E, Rosenthal DI, Tao YG, Wang RS, Wee J, Xu ZY, Yi JL, Yom SS, Fan DM, Mai HQ, Pan JJ, Lee AWM. International Consensus Guideline on Delineation of the Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma (2024 Version). Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):415-431. doi: 10.1016/j.ijrobp.2025.05.019. Epub 2025 May 24.
Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27.
Other Identifiers
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2024-FXY-483
Identifier Type: -
Identifier Source: org_study_id
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