Klinisk utvecklingsarbete för utvärdering av molykulärt riktad behandling vid metastaserande njurcancer- PETTO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003328-45-SE

Enrollment

Registered

2008-07-15

Start date

2008-10-03

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastaserande njurcancer

Interventions

Trade Name: Torisel Product Name: TORISEL, (Temsirolimus) Product Code: EMEA/H/C/799/001 Pharmaceutical Form: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with metastatic renal cell carcinoma in progress after treatment with Sorafenib or Sunitinib. Patients with poor prognosis who are ase sed to have benfit from Temsirolimus treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes mellitus Claustrophobia Extreme obesety

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if changes in FDG uptake measured by PET after one month of Temsirolimus treatment can predict a later clinical response. ;Secondary Objective: To study if the metabolic effect (measured FDG - PET) of temsirolimus in metastatic renalcell carcinoma is different in the different histologcical subtypes and in different metastacic sites.;Primary end point(s): Change in FDG uptake after one month treatment with Temsirolimus compared to baseline. Correlation between the change in FDG uptake after one month treatment with Temsirolimus, with progression free survial and tumor response, (procent change in tumor burden from baseline according to RESIST).	—

Measure

Time frame

Main Objective: To study if changes in FDG uptake measured by PET after one month of Temsirolimus treatment can predict a later clinical response. ;Secondary Objective: To study if the metabolic effect (measured FDG - PET) of temsirolimus in metastatic renalcell carcinoma is different in the different histologcical subtypes and in different metastacic sites.;Primary end point(s): Change in FDG uptake after one month treatment with Temsirolimus compared to baseline. Correlation between the change in FDG uptake after one month treatment with Temsirolimus, with progression free survial and tumor response, (procent change in tumor burden from baseline according to RESIST).

—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026