Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma

Официальное название

Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)

Обзор

To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.

Подробное описание

This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.

Вмешательства

• Лучевая терапия Reduction CTVp1
  High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
• Лучевая терапия Non-reduction CTVp1
  High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)

Первичные конечные точки

• Local Relapse-free Survival(LRFS) [Срок оценки: 3 years]
• Incidence of hearing impairment worse than graded 2 [Срок оценки: 3 years]

Вторичные конечные точки (9)

• Overall survival (OS) [Срок оценки: 3 years]
• Regional Relapse-free Survival(RRFS) [Срок оценки: 3 years]
• Distant metastasis-free survival (DMFS) [Срок оценки: 3 years]
• Acute toxicities [Срок оценки: 3 months]
• Late toxicities [Срок оценки: 3 years]
• Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) [Срок оценки: 3 years]
• Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) [Срок оценки: 3 years]
• radiation-induced otitis media with effusion (OME) [Срок оценки: 3 years]
• V60Gy [Срок оценки: 3 years]

Критерии участия

Критерии включения

• histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
• newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
• nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
• planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
• no previous treatment for cancer；
• a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
• between 18 and 70 years old;
• adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Patients must be informed of the investigational nature of this study and give written informed consent.

Критерии исключения

• receipt of treatment with palliative intent;
• receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx;
• had disease progress after neoadjuvant chemotherapy in local advantage NPC
• presence of distant metastasis;
• Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
• Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
• Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
• lactation or pregnancy;
• Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan City People's Hospital — Zhongshan

Идентификаторы

NCT: NCT05994170 · ZSCPH-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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