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

16. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

568

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Guangdong
      • Dongguan, Guangdong, Kina
        • Har ikke rekruttert ennå
        • Dongguan People's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zhi-Gang Liu, Prof.
      • Foshan, Guangdong, Kina, 528000
        • Har ikke rekruttert ennå
        • First People's Hospital of Foshan
        • Ta kontakt med:
          • Gui-Chao Liu, Dr.
        • Hovedetterforsker:
          • Gui-Chao Liu, Dr.
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Ta kontakt med:
        • Ta kontakt med:
      • Shenzhen, Guangdong, Kina, 518116
        • Har ikke rekruttert ennå
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yan-Ling Wu, Dr.
        • Underetterforsker:
          • Jiang-Hu Zhang, Dr.
      • Zhongshan, Guangdong, Kina, 528400
        • Har ikke rekruttert ennå
        • Zhongshan City People's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gui-Qiong Xu
    • Hunan
      • Changsha, Hunan, Kina
        • Har ikke rekruttert ennå
        • Xiangya Hospital Central South University
        • Ta kontakt med:
          • Liang-Fang Shen, Prof.
          • Telefonnummer: +86-13975805137
          • E-post: slf1688@sina.com
        • Hovedetterforsker:
          • Liang-Fang Shen, Prof.
      • Changsha, Hunan, Kina
        • Har ikke rekruttert ennå
        • Hunan Cancer Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ya-Qian Han, Prof.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Fremgangsmåte: 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).
Stråling: 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.
Eksperimentell: 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.
Fremgangsmåte: 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).
Stråling: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Local relapse-free survival (LRFS)
Tidsramme: 3 years
Local relapse-free survival is estimated from randomisation to documented local relapse or death.
3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Forekomst av strålebehandlingsrelaterte komplikasjoner rapportert av forskeren
Tidsramme: Innenfor (akutt komplikasjon) / siden (sen komplikasjon) 90 dager etter starten av strålebehandlingen.
Innenfor (akutt komplikasjon) / siden (sen komplikasjon) 90 dager etter starten av strålebehandlingen.
Incidence rate of patient-reported adverse events
Tidsramme: Periprocedural.
Periprocedural.
Quality of life (QoL): questionnaire
Tidsramme: Up to 5 years.
Up to 5 years.
Overall survival (OS)
Tidsramme: 3 years
Overall survival is measured from the date of randomisation until death from any cause.
3 years
Failure-free survival (FFS)
Tidsramme: 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)
Tidsramme: 3 years
Distant metastasis-free survival is calculated from randomisation to documented distant metastasis or death.
3 years
Locoregional relapse-free survival (LRFFS)
Tidsramme: 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)
Tidsramme: 3 years
Regional relapse-free survival is defined as the time from randomisation to documented nodal relapse or death.
3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sun Yat-sen University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juli 2026

Primær fullføring (Antatt)

30. juli 2029

Studiet fullført (Antatt)

30. juli 2034

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-FXY-200-FLK

Plan for individuelle deltakerdata (IPD)

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