Clinical trial NCT00700258: 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]
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell, Advanced
Lymphoma, Mantle-Cell
Gastrointestinal Stroma Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 1520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST)

Gastro-Intestinal Stroma Tumor

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

Eligibility criteria: Inclusion Criteria:

* Patients with proven tumor of RCC, MCL or GIST by histology.
* Informed consent signed by patient.

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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
measure: Progression Free Survival (PFS)
timeFrame: 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
measure: Number of Participants With Best Overall Response (BOR)
timeFrame: 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
measure: Number of Participants Categorized According to Physician's Global Assessment of Effectiveness
timeFrame: 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
measure: Karnofsky Performance Status (KPS) Scale
timeFrame: 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
measure: Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma
timeFrame: 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
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: 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
measure: Number of Participants Who Discontinued Treatment Due to Adverse Events
timeFrame: 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
measure: Number of Participants Categorized According to Physician's Global Tolerability Assessment
timeFrame: 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
measure: Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Hematology Parameters: Hemoglobin
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)
timeFrame: Week 46 up to Week 55 post study inclusion
measure: Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)
timeFrame: Week 46 up to Week 55 post study inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-württemberg
city: Neumuenster
country: Germany
facility: Dr. med. Harald Held
state: Schleswig-holstein
city: Ahaus
country: Germany
facility: Dr. med. Hans Wilhelm Duebbers
city: Amberg
country: Germany
facility: Dr. Ludwig Fischer von Weikersthal
city: Aschaffenburg
country: Germany
facility: Group Practice Doctors Klausmann
city: Aschaffenburg
country: Germany
facility: Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie
city: Bautzen
country: Germany
facility: Office of Detlef Muller
city: Bayreuth
country: Germany
facility: Medilei GmbH
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite Campus
city: Bernburg
country: Germany
facility: Carsten Lange
city: Chemnitz
country: Germany
facility: Office of Axel Belusa
city: Chemnitz
country: Germany
facility: Office of Ulrich Kube
city: Chemnitz
country: Germany
facility: Dr. Jens-Uwe Krieger
city: Chemnitz
country: Germany
facility: Zeisigwaldklinikum Bethanien Chemnitz
city: Deggendorf
country: Germany
facility: Leonhard Stark
city: Dessau
country: Germany
facility: Prof. Dr. med. Udo Rebmann
city: Dresden
country: Germany
facility: doctor's office Dr. Göhler
city: Dresden
country: Germany
facility: Dr.med Johannes Mohm
city: Eisleben
country: Germany
facility: Dr. med. Ralf Eckert
city: Erfurt
country: Germany
facility: Specialist Urology
city: Erlangen
country: Germany
facility: Goebell
city: Frankfurt am Main
country: Germany
facility: Prof. Dr. med. Lothar Bergmann
city: Frankfurt am Main
country: Germany
facility: Dr. med. Gunter Derigs
city: Fulda
country: Germany
facility: Hoffkes
city: Greifswald
country: Germany
facility: PD Dr. Uwe Zimmermann
city: Guestrow
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Göttingen
country: Germany
facility: Dr. med. Arne Strauss
city: Hamburg
country: Germany
facility: Dr. med. Michael Rink
city: Hameln
country: Germany
facility: Office of Oleg Rubanov
city: Hof
country: Germany
facility: Dr. med. Hanns-Detlev Harich
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
city: Jena
country: Germany
facility: Dr. med. Susan Foller
city: Kaiserslautern
country: Germany
facility: Office of Richard Hansen
city: Koeln
country: Germany
facility: Steinmetz
city: Koeln
country: Germany
facility: Klinisches Studienzentrum Urlogie
city: Kronach
country: Germany
facility: Dr. med. Martina Stauch
city: Landshut
country: Germany
facility: Dr. med. Ursula Vehling-Kaiser
city: Langen
country: Germany
facility: Dr. Andreas Kohler
city: Leipzig
country: Germany
facility: Dietel
city: Leipzig
country: Germany
facility: Andreas Schwarzer
city: Leipzig
country: Germany
facility: Resident Doctor
city: Luckenwalde
country: Germany
facility: DRK Krankenhaus Luckenwalde
city: Markkleeberg
country: Germany
facility: Dr.med. Matthias Schulze
city: Mayen
country: Germany
facility: Institut of Healthcare Research
city: Moers
country: Germany
facility: OnkoLog GbR
city: Mulheim
country: Germany
facility: Dr. med. Jan Klaus Schroder
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend
city: München
country: Germany
facility: Dr.med. Wolfgang Abenhardt
city: Münster
country: Germany
facility: Boegemann
city: Neckarsulm
country: Germany
facility: Dr. med. Thomas Gehring
city: Neunkirchen
country: Germany
facility: Dres. Derouet Poenicke Becker
city: Neuwied
country: Germany
facility: Physician for Internal Medicine
city: Nienburg
country: Germany
facility: Dr. med. David Kunst
city: Nordhausen
country: Germany
facility: Dr.med. Christian Linder
city: Nürnberg
country: Germany
facility: Dr. med. Joachim Zimber
city: Oldenburg
country: Germany
facility: Ralf-Bodo Kühn
city: Osnabruck
country: Germany
facility: Prof. Dr. med. Ruhnke
city: Ostfildern
country: Germany
facility: Dr. med. Torsten Geyer
city: Parchim
country: Germany
facility: Dr. med. Ino Kietz
city: Plauen =
country: Germany
facility: Praxis
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Rostock
country: Germany
facility: Andreas Hübner
city: Saalfeld
country: Germany
facility: Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum gGmbH
city: Schwäbisch Hall
country: Germany
facility: Dr. med. Thomas Geer
city: Soest
country: Germany
facility: MVZ Kloster Paradiese GbR
city: Speyer
country: Germany
facility: Office of Judith Franz-Werner
city: Stolberg
country: Germany
facility: Dr. Matthias Groschek
city: Trier
country: Germany
facility: Dr. med. Heinz Kirchen
city: Tuebingen
country: Germany
facility: Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,
city: Weiden
country: Germany
facility: Klotz
city: Westerstede
country: Germany
facility: Dr.med. Jan Janssen
city: Wilhelmshaven
country: Germany
facility: ZAS - Zentrum fuer angewandte Studien
city: Wuerzburg
country: Germany
facility: Universitaetsklinik Wuerzburg, Medizinische Poliklinik
city: Wuppertal
country: Germany
facility: Jochen Gleissner
city: Zittau
country: Germany
facility: Mathias Schulze
city: Zwickau
country: Germany
facility: Scheffler
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Strauss 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.
citation: Boegemann 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.