- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05009446
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM (SNMM)
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Xiaole Song, MD
- Telefonnummer: 15821388769
- E-post: jxfxsxl@163.com
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200031
- Rekruttering
- Eye& ENT Hospital, Fudan University
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Ta kontakt med:
- Weifang Wang
- Telefonnummer: 13916229507
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Underetterforsker:
- Xiaoshen Wang, MD,PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
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2 year Overall Survival rate
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From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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the date of first treatment to the first recording of disease progression or death from any cause.
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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
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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
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the date of first treatment to local failure or death
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From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
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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
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the date of first treatment to regional failure or death
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From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
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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
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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
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ORR
Tidsramme: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
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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
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hongmeng Yu, MD,PhD, Eye& ENT Hospital of Fudan University, Shanghai, China
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SNMM-SA-RTNeo
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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