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]
- Conditions
- Lymphoma, Mantle-CellCarcinoma, Renal Cell, AdvancedGastrointestinal Stroma Tumors
- Interventions
- Registration Number
- NCT00700258
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines.
Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib.
The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, 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.
Therefore, the following information is of particular interest in the course of the investigation:
* Efficacy (best response, overall survival, progression-free survival)
* Tolerability of the therapy (assessed by the physician)
* Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta®
* Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta®
* The sequence of using the systemic therapies for RCC, MCL, and GIST
* Patient survey on the quality of life of mRCC patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1520
- Patients with proven tumor of RCC, MCL or GIST by histology.
- Informed consent signed by patient.
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3 Sunitinib Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting 1 Temsirolimus Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings. 2 Temsirolimus Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting 5 Axitinib Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC) 4 Sunitinib Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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 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.
Progression Free Survival (PFS) 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 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.
Number of Participants With Best Overall Response (BOR) 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 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.
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness 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 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.
Karnofsky Performance Status (KPS) Scale 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 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.
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma 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 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) 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 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.
Number of Participants Who Discontinued Treatment Due to 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 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.
Number of Participants Categorized According to Physician's Global Tolerability Assessment 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 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.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Office of Detlef Muller
🇩🇪Bautzen, Germany
Klotz
🇩🇪Weiden, Germany
Carsten Lange
🇩🇪Bernburg, Germany
Goebell
🇩🇪Erlangen, Germany
Dr. med. Hans Wilhelm Duebbers
🇩🇪Ahaus, Germany
Medilei GmbH
🇩🇪Bayreuth, Germany
Group Practice Doctors Klausmann
🇩🇪Aschaffenburg, Germany
Office of Ulrich Kube
🇩🇪Chemnitz, Germany
Zeisigwaldklinikum Bethanien Chemnitz
🇩🇪Chemnitz, Germany
Leonhard Stark
🇩🇪Deggendorf, Germany
Dr. Ludwig Fischer von Weikersthal
🇩🇪Amberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-württemberg, Germany
Hoffkes
🇩🇪Fulda, Germany
Dr. med. Arne Strauss
🇩🇪Göttingen, Germany
Dr. med. Gunter Derigs
🇩🇪Frankfurt am Main, Germany
Dr. med. Ursula Vehling-Kaiser
🇩🇪Landshut, Germany
Jochen Gleissner
🇩🇪Wuppertal, Germany
Mathias Schulze
🇩🇪Zittau, Germany
Universitaetsklinik Wuerzburg, Medizinische Poliklinik
🇩🇪Wuerzburg, Germany
ZAS - Zentrum fuer angewandte Studien
🇩🇪Wilhelmshaven, Germany
Dr.med. Jan Janssen
🇩🇪Westerstede, Germany
Dr. med. Harald Held
🇩🇪Neumuenster, Schleswig-holstein, Germany
Dr.med. Wolfgang Abenhardt
🇩🇪München, Germany
Scheffler
🇩🇪Zwickau, Germany
doctor's office Dr. Göhler
🇩🇪Dresden, Germany
Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie
🇩🇪Aschaffenburg, Germany
Office of Axel Belusa
🇩🇪Chemnitz, Germany
Universitaetsklinikum Charite Campus
🇩🇪Berlin, Germany
Dr. Jens-Uwe Krieger
🇩🇪Chemnitz, Germany
Specialist Urology
🇩🇪Erfurt, Germany
Prof. Dr. med. Udo Rebmann
🇩🇪Dessau, Germany
Dr. med. Ralf Eckert
🇩🇪Eisleben, Germany
Dr.med Johannes Mohm
🇩🇪Dresden, Germany
Prof. Dr. med. Lothar Bergmann
🇩🇪Frankfurt am Main, Germany
PD Dr. Uwe Zimmermann
🇩🇪Greifswald, Germany
Office of Oleg Rubanov
🇩🇪Hameln, Germany
Internistische Gemeinschaftspraxis
🇩🇪Guestrow, Germany
Dr. med. Hanns-Detlev Harich
🇩🇪Hof, Germany
Steinmetz
🇩🇪Koeln, Germany
Dr. med. Michael Rink
🇩🇪Hamburg, Germany
Dr. med. Susan Foller
🇩🇪Jena, Germany
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
🇩🇪Homburg/Saar, Germany
Dr. med. Martina Stauch
🇩🇪Kronach, Germany
Resident Doctor
🇩🇪Leipzig, Germany
Klinisches Studienzentrum Urlogie
🇩🇪Koeln, Germany
Dr. Andreas Kohler
🇩🇪Langen, Germany
Andreas Schwarzer
🇩🇪Leipzig, Germany
Dr.med. Matthias Schulze
🇩🇪Markkleeberg, Germany
Dietel
🇩🇪Leipzig, Germany
DRK Krankenhaus Luckenwalde
🇩🇪Luckenwalde, Germany
Institut of Healthcare Research
🇩🇪Mayen, Germany
OnkoLog GbR
🇩🇪Moers, Germany
Stauferklinikum Schwaebisch Gmuend
🇩🇪Mutlangen, Germany
Dr. med. Jan Klaus Schroder
🇩🇪Mulheim, Germany
Boegemann
🇩🇪Münster, Germany
Dr. med. Thomas Gehring
🇩🇪Neckarsulm, Germany
Dres. Derouet Poenicke Becker
🇩🇪Neunkirchen, Germany
Dr. med. David Kunst
🇩🇪Nienburg, Germany
Dr. med. Joachim Zimber
🇩🇪Nürnberg, Germany
Physician for Internal Medicine
🇩🇪Neuwied, Germany
Ralf-Bodo Kühn
🇩🇪Oldenburg, Germany
Dr.med. Christian Linder
🇩🇪Nordhausen, Germany
Prof. Dr. med. Ruhnke
🇩🇪Osnabruck, Germany
Dr. med. Torsten Geyer
🇩🇪Ostfildern, Germany
Andreas Hübner
🇩🇪Rostock, Germany
Dr. med. Ino Kietz
🇩🇪Parchim, Germany
Diakonie-Klinikum gGmbH
🇩🇪Schwäbisch Hall, Germany
Praxis
🇩🇪Plauen =, Germany
Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie
🇩🇪Saalfeld, Germany
Oncologianova GmbH
🇩🇪Recklinghausen, Germany
Dr. med. Thomas Geer
🇩🇪Schwäbisch Hall, Germany
MVZ Kloster Paradiese GbR
🇩🇪Soest, Germany
Office of Judith Franz-Werner
🇩🇪Speyer, Germany
Dr. med. Heinz Kirchen
🇩🇪Trier, Germany
Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,
🇩🇪Tuebingen, Germany
Dr. Matthias Groschek
🇩🇪Stolberg, Germany
Office of Richard Hansen
🇩🇪Kaiserslautern, Germany