- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00918775
Oppfølging etter metastasektomi hos pasienter med nyrekreft
En fase II-metastasektomistudie for pasienter med nyrecellekarsinom
This phase II trial studies the follow-up after metastasectomy in patients with kidney cancer. Following up patients' health condition after metastasectomy may help doctors to learn if the surgical removal of the primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients who have kidney cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To assess the 24-week progression free/relapse free survival rate in patients undergoing metastasectomy for metastatic renal cell carcinoma (mRCC).
SECONDARY OBJECTIVES:
I. To evaluate progression free survival (PFS), relapse free survival (RFS) and overall survival (OS) in patients undergoing metastasectomy.
II. To evaluate tissue determinants predictive for resectability, PFS and OS in patients undergoing metastasectomy.
OUTLINE:
After metastasectomy, patients are followed up every 6 months for up to 5 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Patients with histologically or cytologically confirmed renal cell carcinoma (RCC)
-
Patients have clinical reasons for undergoing a surgical resection of tumor; there are two main categories of patients:
- Patients with fully resectable disease as defined by lesions accessible by a surgeon during no more than two separate surgical sessions, and are expected to be rendered surgically no evidence of disease (NED)
- Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions
-
Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
-
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy; the only approved consent is attached to this protocol
-
Patients must have ability to comply with study and/or follow-up procedures
-
Members of all races and ethnic groups are eligible for this trial
Exclusion Criteria:
- Patients must not have active acute infections that could be worsened by surgery or interfere with this study
- Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk
- Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates surgical resection, or render the subject at high risk from treatment complications
- Patients must not have a history of uncontrolled severe depression
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Observational (follow-up)
After metastasectomy, patients are followed up every 6 months for up to 5 years. |
Correlative studies Undergo follow-up |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery
Tidsramme: 24 weeks
|
Assessed using a logistic regression model. |
24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progresjonsfri overlevelse (PFS)
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
|
|
Overall survival (OS)
Tidsramme: Up to 5 years
|
Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. |
Up to 5 years
|
|
Disease free survival (DFS)
Tidsramme: Up to 5 years
|
Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. |
Up to 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eric Jonasch, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
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
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Urologiske neoplasmer
- Karsinom
- Nyre-neoplasmer
- Karsinom, nyrecelle
- Health Services Administration
- Terapeutikk
- Pasientbehandling
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Kontinuitet i pasientbehandling
- Pasientbehandling
- Omfattende helsehjelp
- Primær helsehjelp
- Ettervern
Andre studie-ID-numre
- 2009-0038
- 2009-0038 (Annen identifikator: M D Anderson Cancer Center)
- NCI-2017-00524 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- R01CA90370 (Annen identifikator: National Cancer Institute)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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