- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00460798
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma (SUNIKA)
A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be
1 year.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- First-line treatment in patients with metastatic renal cell carcinoma
Exclusion Criteria:
- Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Ikke-intervensjonell studie
|
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Categorical Best Overall Response
Tidsramme: Start of Treatment up through 12 Months or Early Discontinuation
|
Best overall reponse based on investigator's disease status assessment.
Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions.
Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
|
Start of Treatment up through 12 Months or Early Discontinuation
|
Number of Participants With Objective Response
Tidsramme: 12 Months or Early Discontinuation
|
Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST).
CR was defined as disappearance of all target lesions.
PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
|
12 Months or Early Discontinuation
|
Time to Progression (TTP)
Tidsramme: Start of Treatment up through 12 Months or Early Discontinuation
|
TTP = time from date of first dose to date of first recording of PD.
Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.
|
Start of Treatment up through 12 Months or Early Discontinuation
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Tidsramme: Baseline, 3, 6, 9 and 12 Months
|
ECOG performance status measured on 6 point scale to assess participant's performance status.
0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead.
0=Best status, 5=Worst status
|
Baseline, 3, 6, 9 and 12 Months
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
Tidsramme: Baseline, 3, 6, 9 and 12 Months
|
EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
All scales and single-item measures range=0 to 100.
High score for a functional scale=high/healthy level of functioning.
High score for global health status/QoL=high QoL.
High score for symptom scale/single item=high level of symptomatology/problems
|
Baseline, 3, 6, 9 and 12 Months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Nyre-neoplasmer
- Karsinom, nyrecelle
- Karsinom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Sunitinib
Andre studie-ID-numre
- A6181115
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. .
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