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

16 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

568

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Guangdong
      • Dongguan, Guangdong, Cina
        • Non ancora reclutamento
        • Dongguan People's Hospital
        • Contatto:
        • Investigatore principale:
          • Zhi-Gang Liu, Prof.
      • Foshan, Guangdong, Cina, 528000
        • Non ancora reclutamento
        • First People's Hospital of Foshan
        • Contatto:
          • Gui-Chao Liu, Dr.
        • Investigatore principale:
          • Gui-Chao Liu, Dr.
      • Guangzhou, Guangdong, Cina
        • Reclutamento
        • Sun Yat-sen University Cancer Center
        • Contatto:
        • Contatto:
      • Shenzhen, Guangdong, Cina, 518116
        • Non ancora reclutamento
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
        • Contatto:
        • Investigatore principale:
          • Yan-Ling Wu, Dr.
        • Sub-investigatore:
          • Jiang-Hu Zhang, Dr.
      • Zhongshan, Guangdong, Cina, 528400
        • Non ancora reclutamento
        • Zhongshan City People's Hospital
        • Contatto:
        • Investigatore principale:
          • Gui-Qiong Xu
    • Hunan
      • Changsha, Hunan, Cina
        • Non ancora reclutamento
        • Xiangya Hospital Central South University
        • Contatto:
          • Liang-Fang Shen, Prof.
          • Numero di telefono: +86-13975805137
          • Email: slf1688@sina.com
        • Investigatore principale:
          • Liang-Fang Shen, Prof.
      • Changsha, Hunan, Cina
        • Non ancora reclutamento
        • Hunan Cancer Hospital
        • Contatto:
        • Investigatore principale:
          • Ya-Qian Han, Prof.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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).
Radiazione: 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.
Sperimentale: 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.
Procedura: 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).
Radiazione: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Local relapse-free survival (LRFS)
Lasso di tempo: 3 years
Local relapse-free survival is estimated from randomisation to documented local relapse or death.
3 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidenza di complicanze correlate alla radioterapia segnalate dallo sperimentatore
Lasso di tempo: Entro (complicazione acuta) / da (complicazione tardiva) 90 giorni dall'inizio della radioterapia.
Entro (complicazione acuta) / da (complicazione tardiva) 90 giorni dall'inizio della radioterapia.
Incidence rate of patient-reported adverse events
Lasso di tempo: Periprocedural.
Periprocedural.
Quality of life (QoL): questionnaire
Lasso di tempo: Up to 5 years.
Up to 5 years.
Overall survival (OS)
Lasso di tempo: 3 years
Overall survival is measured from the date of randomisation until death from any cause.
3 years
Failure-free survival (FFS)
Lasso di tempo: 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)
Lasso di tempo: 3 years
Distant metastasis-free survival is calculated from randomisation to documented distant metastasis or death.
3 years
Locoregional relapse-free survival (LRFFS)
Lasso di tempo: 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)
Lasso di tempo: 3 years
Regional relapse-free survival is defined as the time from randomisation to documented nodal relapse or death.
3 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sun Yat-sen University

Investigatori

  • Investigatore principale: Jun Ma, Prof., Sun Yat-sen University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 luglio 2026

Completamento primario (Stimato)

30 luglio 2029

Completamento dello studio (Stimato)

30 luglio 2034

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-FXY-200-FLK

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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