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
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
- Navn: Xiaole Song, MD
- Telefonnummer: 15821388769
- E-mail: jxfxsxl@163.com
Studiesteder
-
-
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:
- Age over 18 years old;
- Pathologically confirmed with sinonasal mucosal melanoma;
- Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
- 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.
- Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
- No distant metastasis;
- Adequate organ function;
- Sign the informed consent forms.
Exclusion Criteria:
- There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
- suffered from uncontrolled concurrent diseases that may interfere with treatment;
- 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.);
- With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
- With and conditions that interfere with patient compliance or safety;
- With severe mental or neurological diseases;
- Uncontrolled active infection diseases;
- Pregnant or breastfeeding women;
- Patients without personal freedom or independent civil capacity;
- 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
|
endoscopic surgery or endoscope-assisted surgery open surgery
radiotherapy was administrated before surgery
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
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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
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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.
Samarbejdspartnere
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SNMM-SA-RTNeo
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