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Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma (CTV-MARGIN-NPC)

16 de agosto de 2026 atualizado por: Jun Ma, MD, Sun Yat-sen University

Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial

This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This multicenter, prospective, randomized phase 3 trial aims to evaluate a margin-expansion-based primary clinical target volume (CTVp) delineation strategy in patients with newly diagnosed non-metastatic nasopharyngeal carcinoma (NPC). The primary objective is to demonstrate non-inferiority of this CTVp approach compared with the consensus CTVp defined by the CSTRO, CACA, CSCO, HNCIG, ESTRO, and ASTRO guidelines (which incorporate both margin expansion and local stepwise extension patterns), with local relapse-free survival as the primary endpoint. Secondary objectives include comparisons of overall survival, failure-free survival, distant metastasis-free survival, locoregional relapse-free survival, and regional relapse-free survival between the two CTVp strategies, as well as assessments of radiotherapy-related complications, quality of life, and their impact on the tumor immune microenvironment, along with exploration of the underlying biological mechanisms.

Eligible patients will be prospectively enrolled from multiple centers across China and randomized in a 1:1 ratio to receive either the margin-based CTVp or the consensus guideline-based CTVp. Comprehensive treatment in both arms will follow current clinical guidelines and be stratified by tumor stage. Prognosis, toxicity, and quality-of-life outcomes will be systematically compared between the two groups.

Tipo de estudo

Intervencional

Inscrição (Estimado)

568

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Guangdong
      • Dongguan, Guangdong, China
        • Ainda não está recrutando
        • Dongguan People's Hospital
        • Contato:
        • Investigador principal:
          • Zhi-Gang Liu, Prof.
      • Foshan, Guangdong, China, 528000
        • Ainda não está recrutando
        • First People's Hospital of Foshan
        • Contato:
          • Gui-Chao Liu, Dr.
        • Investigador principal:
          • Gui-Chao Liu, Dr.
      • Guangzhou, Guangdong, China
        • Recrutamento
        • Sun Yat-sen University Cancer Center
        • Contato:
        • Contato:
      • Shenzhen, Guangdong, China, 518116
        • Ainda não está recrutando
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
        • Contato:
        • Investigador principal:
          • Yan-Ling Wu, Dr.
        • Subinvestigador:
          • Jiang-Hu Zhang, Dr.
      • Zhongshan, Guangdong, China, 528400
        • Ainda não está recrutando
        • Zhongshan City People's Hospital
        • Contato:
        • Investigador principal:
          • Gui-Qiong Xu
    • Hunan
      • Changsha, Hunan, China
        • Ainda não está recrutando
        • Xiangya Hospital Central South University
        • Contato:
          • Liang-Fang Shen, Prof.
          • Número de telefone: +86-13975805137
          • E-mail: slf1688@sina.com
        • Investigador principal:
          • Liang-Fang Shen, Prof.
      • Changsha, Hunan, China
        • Ainda não está recrutando
        • Hunan Cancer Hospital
        • Contato:
        • Investigador principal:
          • Ya-Qian Han, Prof.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age: 18 Years to 65 Years.
  2. Eastern Cooperative Oncology Group performance status ≤1.
  3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype).
  4. Tumor staged as T1-4N0-3M0 (AJCC 9th).
  5. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
  6. Women of childbearing potential and male subjects with female partners of childbearing potential must agree to use reliable contraceptive measures from screening to 1 year after treatment.

  7. For subjects requiring chemotherapy, the following are additionally required:

    1. normal bone marrow function (white blood cell count > 4 × 10^9/L, hemoglobin > 90 g/L, platelet count > 100 × 10^9/L);
    2. normal liver and kidney function (total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2.5 × upper limit of normal, alkaline phosphatase ≤ 2.5 × upper limit of normal, creatinine clearance rate ≥ 60 mL/min).

Exclusion Criteria:

  1. Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis > 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.
  2. Active infection requiring systemic treatment.
  3. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer.
  4. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma.
  5. Prior or concurrent treatment for local or regional disease other than that specified in the research plan.
  6. Pregnant or lactating women (a pregnancy test is required for women of childbearing potential).
  7. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast.
  8. History of psychiatric disorders, alcoholism or drug abuse, and other situations assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

  9. For participants requiring chemotherapy, the following must also be excluded:

    1. anti-human immunodeficiency virus positive or diagnosed with acquired immune deficiency syndrome;
    2. uncontrolled heart disease (heart failure [NYHA Class ≥ 2], unstable angina, myocardial infarction in past 1 year, supraventricular or ventricular arrhythmia requiring treatment or intervention).

  10. For participants requiring immunotherapy, the following must also be excluded:

    1. hepatitis B virus surface antigen positive and Hepatitis B virus DNA > 1000 copies/mL;
    2. anti-hepatitis C virus positive;
    3. active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators, exceptions are type I diabetes mellitus, hypothyroidism not requiring hormone replacement therapy, skin disorders not requiring systemic treatment [such as vitiligo, psoriasis or alopecia]);
    4. previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
    5. chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day, subjects who use inhaled or topical corticosteroids are eligible) or any other form of immunosuppressive therapy;
    6. allergy to macromolecular protein preparations, or any component of PD-1 monoclonal antibody;
    7. receiving live vaccine within 30 days prior to the first dose of PD-1 monoclonal antibody.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Consensus Primary Clinical Target Volume Based on Margin Expansion and Stepwise Extension Pattern
During radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion and local stepwise extension patterns according to the CSTRO, CACA, CSCO, HNCIG, ESTRO, and ASTRO guidelines and contouring atlas.
Procedimento: Comprehensive Therapy Based on Tumor Stage
  1. T1N0: Radiotherapy Only.
  2. T1N1, T2N0-1, T3N0: Radiotherapy with or without Concurrent Chemotherapy (Cisplatin).
  3. T3N1, T4N0: Concurrent Chemoradiotherapy (Cisplatin) with or without Induction Chemotherapy (GP Regimen).
  4. T1-4N2-3, T4N1: ① Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin); ② Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody); ③ Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).
Radiação: IMRT with Consensus Primary Clinical Target Volume

  1. Target delineation:

    1. CTVp_High = GTVp + 0 mm;
    2. CTVp_Mid = CTVp_High + 5 mm;
    3. CTVp_Low = CTVp_Mid + 5 mm + whole nasopharynx + high-risk structures based on stepwise local extension patterns of tumor spread;
    4. CTVn_High = GTVn + 0 mm;
    5. CTVn_Mid = CTVn_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results;
    6. CTVn_Low = CTVn_Mid + 3 mm + elective drainage levels;

  2. Dose prescription:

    1. 6996 cGy/33 fx for CTVp_High and CTVn_High;
    2. 6006 cGy/33 fx for CTVp_Mid and CTVn_Mid;
    3. 5412 cGy/33 fx for CTVp_Low and CTVn_Low.
Experimental: Primary Clinical Target Volume Based on Margin Expansion
During radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion.
Procedimento: Comprehensive Therapy Based on Tumor Stage
  1. T1N0: Radiotherapy Only.
  2. T1N1, T2N0-1, T3N0: Radiotherapy with or without Concurrent Chemotherapy (Cisplatin).
  3. T3N1, T4N0: Concurrent Chemoradiotherapy (Cisplatin) with or without Induction Chemotherapy (GP Regimen).
  4. T1-4N2-3, T4N1: ① Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin); ② Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody); ③ Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).
Radiação: IMRT with Primary Clinical Target Volume Based on Margin Expansion

  1. Target delineation:

    1. CTVp_High = GTVp + 0 mm;
    2. CTVp_Mid = CTVp_High + 5 mm;
    3. CTVp_Low = CTVp_Mid + 5 mm + whole nasopharynx;
    4. CTVn_High = GTVn + 0 mm;
    5. CTVn_Mid = CTVn_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results;
    6. CTVn_Low = CTVn_Mid + 3 mm + elective drainage levels.

  2. Dose prescription:

    1. 6996 cGy/33 fx for CTVp_High and CTVn_High;
    2. 6006 cGy/33 fx for CTVp_Mid and CTVn_Mid;
    3. 5412 cGy/33 fx for CTVp_Low and CTVn_Low.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Local relapse-free survival (LRFS)
Prazo: 3 years
Local relapse-free survival is estimated from randomisation to documented local relapse or death.
3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Taxa de incidência de complicações relacionadas com radioterapia relatadas pelo investigador
Prazo: No prazo de (complicação aguda) / desde (complicação tardia) 90 dias após o início da radioterapia.
No prazo de (complicação aguda) / desde (complicação tardia) 90 dias após o início da radioterapia.
Incidence rate of patient-reported adverse events
Prazo: Periprocedural.
Periprocedural.
Quality of life (QoL): questionnaire
Prazo: Up to 5 years.
Up to 5 years.
Overall survival (OS)
Prazo: 3 years
Overall survival is measured from the date of randomisation until death from any cause.
3 years
Failure-free survival (FFS)
Prazo: 3 years
Failure-free survival is measured from the date of randomisation until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurs first.
3 years
Distant metastasis-free survival (DMFS)
Prazo: 3 years
Distant metastasis-free survival is calculated from randomisation to documented distant metastasis or death.
3 years
Locoregional relapse-free survival (LRFFS)
Prazo: 3 years
Locoregional relapse-free survival is measured from the date of randomisation until local or regional recurrence or death.
3 years
Regional relapse-free survival (RRFS)
Prazo: 3 years
Regional relapse-free survival is defined as the time from randomisation to documented nodal relapse or death.
3 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sun Yat-sen University

Investigadores

  • Investigador principal: Jun Ma, Prof., Sun Yat-sen University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de julho de 2026

Conclusão Primária (Estimado)

30 de julho de 2029

Conclusão do estudo (Estimado)

30 de julho de 2034

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-FXY-200-FLK

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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