Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib
Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma
1 other identifier
interventional
22
1 country
14
Brief Summary
This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed. In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedJuly 10, 2012
July 1, 2012
3 years
September 9, 2009
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression
7-11 months expected
Secondary Outcomes (4)
Objective response
7-11 months expected
safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs
8-12 months (treatment duration + 1 months)
one year progression free survival rate (1YPFSR)
1 year
overall survival (OS)
will be evaluated in 2013
Study Arms (2)
A
EXPERIMENTALTemsirolimus
B
EXPERIMENTALSunitinib
Interventions
Eligibility Criteria
You may qualify if:
- Adult males and females: ≥18 years of age.
- Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
- Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: ≥ 1 measurable lesion that has not been irradiated.
- PS 0-2 ECOG
- Signed written informed consent.
- White blood cell count (WBC) ≥4x10\*9/L with neutrophils ≥1.5 x 10\*9/L, platelet count ≥100x10\*9/L, hemoglobin ≥9 g/dL.\]
- Total bilirubin \<2 x upper limit of normal.
- AST and ALT \<2.5 x upper limit of normal, or \<5 x upper limit of normal in case of liver metastases.
- Serum creatinine \<2.0 x upper limit of normal.
- Normal ECG without QT prolongation (QTc \< 450msec).
- Adequate cardiac function (left ventricular ejection fraction \> 40% as assessed by ECHO.
You may not qualify if:
- Predominant clear-cell RCC
- Resectability or other curative options
- Prior systemic treatment for their RCC.
- Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
- Radiotherapy within the last 4 weeks.
- Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
- Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
- History of any of the following cardiac events within the past 6 months:
- myocardial infarction (including severe/unstable angina),
- coronary/peripheral artery bypass graft,
- congestive heart failure (CHF),
- cerebrovascular accident,
- transient ischemic attack,
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Charité - Campus Virchow Klinikum
Berlin, Germany
Charité - Mitte
Berlin, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus
Bonn, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Universitätskrankenhaus Jena
Jena, Germany
UK-SH Campus Lübeck
Lübeck, Germany
Klinikum Oldenburg gGmbH
Oldenburg, Germany
Klinikum Stuttgart, Katharinenhospital
Stuttgart, Germany
Facharzt für Innere Medizin,
Viersen, Germany
Kliniken Nordoberpfalz AG - Klinikum Weiden
Weiden, Germany
Related Publications (1)
Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PMID: 37146227DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 18, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2012
Last Updated
July 10, 2012
Record last verified: 2012-07