Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity

Официальное название

Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity : an Open-label, Non-inferiority, Multicenter, Randomized Phase III Trial

Обзор

This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.

Подробное описание

This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).

Вмешательства

• Лучевая терапия standard CTV delineation
  The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
• Лучевая терапия reduced CTV delineation
  The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.

Первичные конечные точки

• Local relapse-free survival [Срок оценки: 3 year]

Вторичные конечные точки (6)

• Overall survival [Срок оценки: 3 year]
• Progression-free survival [Срок оценки: 3 year]
• Distant metastasis-free survival [Срок оценки: 3 year]
• Regional relapse-free survival [Срок оценки: 3 year]
• Incidence rate of adverse events (AEs) [Срок оценки: 2 year]
• Change of quality of life [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
• Stage I-III disease (AJCC 9th edition).
• Tumor extends to nasal cavity (including nasal septum).
• No distant metastasis (M0).
• Age 18-70 years.
• Male or non-pregnant female.
• Scheduled for radiotherapy.
• ECOG performance status 0-1 .
• Adequate bone marrow function: white blood cells >4×10⁹/L, hemoglobin >90 g/L, platelets >100×10⁹/L.
• Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min.
• Written informed consent obtained.

Критерии исключения

• Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
• Age <18 or >70 years.
• Recurrent disease or distant metastasis.
• No tumor extension into the nasal cavity (including the nasal septum).
• Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
• Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated).
• Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).
• Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures).
• Severe coexisting illness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• First People's Hospital of Foshan — Foshan
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Affiliated Hospital of Guangdong Medical University — Zhangjiang
• The Fourth Affiliated Hospital of Guangxi Medical University — Liuzhou
• Wuzhou Red Cross Hospital — Wuzhou

Публикации

• 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. BM PMID 36746459
• 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. PMID 30712708
• 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 PMID 40419028
• 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. PMID 22178121
• 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. PMID 19251378

Идентификаторы

NCT: NCT07072000 · 2024-FXY-483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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