Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
STAR-TOR
STAR-TOR- REGISTRY FOR THE EVALUATION OF THE SAFETY, TOLERABILITY AND EFFICACY OF TEMSIROLIMUS (TORISEL), SUNITINIB (SUTENT) AND AXITINIB (INLYTA) FOR THE TREATMENT OF SUBJECTS WITH ADVANCED RENAL CELL CARCINOMA (MRCC), MANTLE CELL LYMPHOMA (MCL) AND GASTRO-INTESTINAL STROMA TUMOR (GIST).
2 other identifiers
observational
1,520
1 country
77
Brief Summary
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2008
Longer than P75 for all trials
77 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
February 13, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2021
CompletedResults Posted
Study results publicly available
September 23, 2024
CompletedSeptember 23, 2024
May 1, 2024
13.9 years
June 13, 2008
December 7, 2022
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (18)
Overall Survival (OS)
OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Progression Free Survival (PFS)
PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants With Best Overall Response (BOR)
BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness
In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Karnofsky Performance Status (KPS) Scale
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 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. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Who Discontinued Treatment Due to Adverse Events
An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Categorized According to Physician's Global Tolerability Assessment
In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Hematology Parameters: Hemoglobin
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)
Week 46 up to Week 55 post study inclusion
Study Arms (5)
1
Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings.
2
Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting
3
Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting
4
Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting
5
Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC)
Interventions
Non-interventional study. Treatment decision already made before inclusion into the registry.
Non-interventional study. Treatment decision already made before inclusion into the registry.
Non-interventional study. Treatment decision already made before inclusion into the registry.
Eligibility Criteria
Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST) Gastro-Intestinal Stroma Tumor
You may qualify if:
- Patients with proven tumor of RCC, MCL or GIST by histology.
- Informed consent signed by patient.
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (77)
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89070, Germany
Dr. med. Harald Held
Neumünster, Schleswig-Holstein, 24534, Germany
Dr. med. Hans Wilhelm Duebbers
Ahaus, 48683, Germany
Dr. Ludwig Fischer von Weikersthal
Amberg, 92224, Germany
Group Practice Doctors Klausmann
Aschaffenburg, 63739, Germany
Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie
Aschaffenburg, 63739, Germany
Office of Detlef Muller
Bautzen, 02625, Germany
Medilei GmbH
Bayreuth, 95445, Germany
Universitaetsklinikum Charite Campus
Berlin, 10117, Germany
Carsten Lange
Bernburg, 06406, Germany
Office of Axel Belusa
Chemnitz, 09117, Germany
Office of Ulrich Kube
Chemnitz, 09119, Germany
Dr. Jens-Uwe Krieger
Chemnitz, 09127, Germany
Zeisigwaldklinikum Bethanien Chemnitz
Chemnitz, 09130, Germany
Steinmetz
Cologne, 50677, Germany
Klinisches Studienzentrum Urlogie
Cologne, 50937, Germany
Leonhard Stark
Deggendorf, 94469, Germany
Prof. Dr. med. Udo Rebmann
Dessau, 06846, Germany
doctor's office Dr. Göhler
Dresden, 01127, Germany
Dr.med Johannes Mohm
Dresden, 01307, Germany
Dr. med. Ralf Eckert
Eisleben Lutherstadt, 06295, Germany
Specialist Urology
Erfurt, 99084, Germany
Goebell
Erlangen, 91054, Germany
Prof. Dr. med. Lothar Bergmann
Frankfurt am Main, 60596, Germany
Dr. med. Gunter Derigs
Frankfurt am Main, 65929, Germany
Hoffkes
Fulda, 36043, Germany
Dr. med. Arne Strauss
Göttingen, 37075, Germany
PD Dr. Uwe Zimmermann
Greifswald, 17475, Germany
Internistische Gemeinschaftspraxis
Güstrow, 18273, Germany
Dr. med. Michael Rink
Hamburg, 20246, Germany
Office of Oleg Rubanov
Hamelin, 31785, Germany
Dr. med. Hanns-Detlev Harich
Hof, 95028, Germany
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
Homburg/Saar, 66421, Germany
Dr. med. Susan Foller
Jena, 07743, Germany
Office of Richard Hansen
Kaiserslautern, 67655, Germany
Dr. med. Martina Stauch
Kronach, 96317, Germany
Dr. med. Ursula Vehling-Kaiser
Landshut, 84028, Germany
Dr. Andreas Kohler
Langen, 63225, Germany
Dietel
Leipzig, 04103, Germany
Andreas Schwarzer
Leipzig, 04289, Germany
Resident Doctor
Leipzig, 04357, Germany
DRK Krankenhaus Luckenwalde
Luckenwalde, 14943, Germany
Dr.med. Matthias Schulze
Markkleeberg, 04416, Germany
Institut of Healthcare Research
Mayen, 56727, Germany
OnkoLog GbR
Moers, 47441, Germany
Stauferklinikum Schwaebisch Gmuend
Mutlangen, 73557, Germany
Dr. med. Jan Klaus Schroder
Mülheim, 45468, Germany
Dr.med. Wolfgang Abenhardt
München, 80335, Germany
Boegemann
Münster, Germany
Dr. med. Thomas Gehring
Neckarsulm, 74172, Germany
Dres. Derouet Poenicke Becker
Neunkirchen, 66538, Germany
Physician for Internal Medicine
Neuwied, 56564, Germany
Dr. med. David Kunst
Nienburg, 31582, Germany
Dr.med. Christian Linder
Nordhausen, 99734, Germany
Dr. med. Joachim Zimber
Nuremberg, 90449, Germany
Ralf-Bodo Kühn
Oldenburg, 26121, Germany
Prof. Dr. med. Ruhnke
Osnabrück, 49076, Germany
Dr. med. Torsten Geyer
Ostfildern, 73760, Germany
Dr. med. Ino Kietz
Parchim, 19370, Germany
Praxis
Plauen, D-08523, Germany
Oncologianova GmbH
Recklinghausen, 45659, Germany
Andreas Hübner
Rostock, 18107, Germany
Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie
Saalfeld, 07318, Germany
Diakonie-Klinikum gGmbH
Schwäbisch Hall, 74523, Germany
Dr. med. Thomas Geer
Schwäbisch Hall, 74523, Germany
MVZ Kloster Paradiese GbR
Soest, 59494, Germany
Office of Judith Franz-Werner
Speyer, 67346, Germany
Dr. Matthias Groschek
Stolberg, 52222, Germany
Dr. med. Heinz Kirchen
Trier, 54292, Germany
Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,
Tübingen, 72076, Germany
Klotz
Weiden, 92637, Germany
Dr.med. Jan Janssen
Westerstede, 26655, Germany
ZAS - Zentrum fuer angewandte Studien
Wilhelmshaven, 26389, Germany
Jochen Gleissner
Wuppertal, 42103, Germany
Universitaetsklinik Wuerzburg, Medizinische Poliklinik
Würzburg, 97070, Germany
Mathias Schulze
Zittau, 02763, Germany
Scheffler
Zwickau, 08060, Germany
Related Publications (3)
Uhlig A, Bergmann L, Bogemann M, Fischer T, Goebell PJ, Leitsmann M, Reichert M, Rink M, Schlack K, Trojan L, Uhlig J, Woike M, Strauss A. Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review. Urol Int. 2024;108(3):198-210. doi: 10.1159/000536563. Epub 2024 Feb 2.
PMID: 38310863DERIVEDStrauss A, Schmid M, Rink M, Moran M, Bernhardt S, Hubbe M, Bergmann L, Schlack K, Boegemann M. Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry. Future Oncol. 2021 Jun;17(18):2325-2338. doi: 10.2217/fon-2020-1020. Epub 2021 Mar 16.
PMID: 33724867DERIVEDBoegemann M, Schlack K, Rink M, Bernhardt S, Moran M, Hubbe M, Bergmann L, Schmid M, Strauss A. Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry. Future Oncol. 2020 Dec;16(35):2939-2948. doi: 10.2217/fon-2020-0548. Epub 2020 Oct 6.
PMID: 33021843DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 18, 2008
Study Start
February 13, 2008
Primary Completion
December 28, 2021
Study Completion
December 28, 2021
Last Updated
September 23, 2024
Results First Posted
September 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.