Immune Response Evaluation to Curative Conventional Therapy (IRECT-01)
Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.
The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
- fit for treatment with curative intent
- conventional primary treatment
- primary surgical treatment
- primary radiotherapeutic treatment
- informed consent
- >18 years of age
- sufficient contraception
Exclusion Criteria:
- distant metastasis at baseline
- severe concomitant disease compromising curative treatment
- previously diagnosed other malignant diseases
- active immunosuppressive therapy
- known immune defect
- pregnancy
- anemia requiring treatment at study entry (<9g/dl)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
primary surgery + adj. C)RT
treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent
|
|
primary chemoradiation
treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
prevalence of spontaneous tumor-specific immunity at baseline
Tidsramme: baseline
|
baseline
|
|
dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
Tidsramme: 7-12 weeks (treatment phase)
|
7-12 weeks (treatment phase)
|
|
dynamics of tumor-specific immunity and immune modulatory cells during follow up
Tidsramme: 12 months after end of treatment
|
12 months after end of treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
overall survival at 3 years
Tidsramme: baseline - 3 years
|
baseline - 3 years
|
|
progression free survival at 3 years
Tidsramme: baseline - 3 years
|
baseline - 3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRECT-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .