Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE) (ORCHIDEE)
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|ClinicalTrials.gov Identifier: NCT02338570|
Recruitment Status : Terminated (Stopped on November 16th 2016, because of recruitment failure.)
First Posted : January 14, 2015
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Everolimus||Phase 4|
Predictive factors to be considered are: histology, Heng risk group, Eastern Cooperative Oncology Group-performance status (ECOG-PS), site of metastases, glycemia and cholesterolemia.
The data collected in this "real life" population could contribute to identify clinical factors that predict favourable outcomes in patients treated with everolimus after failure or a a first-line treatment with a VEGF inhibitor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of a First-line Treatment With VEGF Inhibitor|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
All patients will receive everolimus 10 mg orally per day. Treatment will continue until progression, unacceptable toxicity, patient refusal or medical decision
Patients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets).
Other Name: Afinitor
- predictive factors identification [ Time Frame: 36 months ]To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC). A favourable outcome is being alive and on treatment without both disease progression (according to RECIST 1.1) and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D VAS).
- Progression free survival (PFS) of everolimus as second line treatment [ Time Frame: 36 months ]PFS distributions will be estimated using the Kaplan-Meier method and compared using the log-rank test.
- health related quality of life (HRQoL) [ Time Frame: 36 months ]As measured by EQ-5D questionnaire. It will be described at each time by using summary statistical measures for continuous variables
- drug-related toxicity [ Time Frame: 36 months ]
assessed by the National Cancer Institute-Common Terminology Criteria for adverse events (NCI-CTCAE), version 4.03.
The frequency of maximum toxicity grade experienced by each patient for each specific toxicity will be presented as well as the frequency of patients experiencing grade 3 or 4 (grade 2 for neurotoxicity) events, and SADRs.
- compliance [ Time Frame: 36 months ]Treatment compliance will be assessed by evaluating the dose intensity (total dose divided by duration of exposure to treatment in weeks), and calculating the frequencies and proportion of patients who modified or interrupted the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338570
|Ospedale A Perrino|
|Istituto Europeo di Oncologia|
|Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale|
|AOU Maggiore della Carità|
|Casa di Cura La Maddalena|
|AOU San Giovanni di Dio e Ruggi D'Aragona|
|Principal Investigator:||Giacomo Cartenì||Azienda Ospedaliera "Antonio Cardarelli", Napoli|