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]

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    1600
  • sponsor
    Pfizer
Updated on 25 January 2021
temsirolimus
refractory mantle cell lymphoma

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

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

Details
Condition Mantle cell lymphoma, Carcinoma, Renal Cell, Advanced, Gastrointestinal Stroma Tumors, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced, Carcinoma, Renal Cell, Advanced
Treatment Sunitinib, Temsirolimus, Axitinib
Clinical Study IdentifierNCT00700258
SponsorPfizer
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Pregnancy
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