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Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM (SNMM)

16. august 2021 opdateret af: Hongmeng Yu, Eye & ENT Hospital of Fudan University

A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma

Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment.

There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported.

This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

28

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200031
        • Rekruttering
        • Eye& ENT Hospital, Fudan University
        • Kontakt:
          • Weifang Wang
          • Telefonnummer: 13916229507
        • Underforsker:
          • Xiaoshen Wang, MD,PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age over 18 years old;
  2. Pathologically confirmed with sinonasal mucosal melanoma;
  3. Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
  4. T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion.
  5. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
  6. No distant metastasis;
  7. Adequate organ function;
  8. Sign the informed consent forms.

Exclusion Criteria:

  1. There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
  2. suffered from uncontrolled concurrent diseases that may interfere with treatment;
  3. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.);
  4. With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
  5. With and conditions that interfere with patient compliance or safety;
  6. With severe mental or neurological diseases;
  7. Uncontrolled active infection diseases;
  8. Pregnant or breastfeeding women;
  9. Patients without personal freedom or independent civil capacity;
  10. Other situations that are not suitable.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Preoperative radiotherapy and chemotherapy
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
Procedure: endoscopic surgery
endoscopic surgery or endoscope-assisted surgery open surgery
Stråling: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
radiotherapy was administrated before surgery
Medicin: Chemotherapy drug
Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival
Tidsramme: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
2 year Overall Survival rate
From date of first treatment until the date of death from any cause,through study completion,up to 2 years.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years
the date of first treatment to the first recording of disease progression or death from any cause.
From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years
Local progression free survival
Tidsramme: From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
the date of first treatment to local failure or death
From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
Regional progression free survival
Tidsramme: From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
the date of first treatment to regional failure or death
From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
Distant metastasis free survival
Tidsramme: From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
the date of first treatment to distant metastasis or death
From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
ORR
Tidsramme: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
objective remission rate
From date of first treatment to the date of best overall response before surgery, assessed up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eye & ENT Hospital of Fudan University

Samarbejdspartnere

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Efterforskere

  • Ledende efterforsker: Hongmeng Yu, MD,PhD, Eye& ENT Hospital of Fudan University, Shanghai, China

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

10. august 2021

Primær færdiggørelse (Forventet)

10. august 2025

Studieafslutning (Forventet)

10. august 2025

Datoer for studieregistrering

Først indsendt

18. juli 2021

Først indsendt, der opfyldte QC-kriterier

16. august 2021

Først opslået (Faktiske)

17. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SNMM-SA-RTNeo

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Slimhinde melanom

Kliniske forsøg med endoscopic surgery

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