REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA)
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|ClinicalTrials.gov Identifier: NCT03916458|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Observational, retrospective, multicentre study in spanish patients with metastatic Renal Cell Carcinoma (mRCC) treated with sunitinib as a first-line treatment (treatment with previous cytokine therapy is accepted) according to clinical practice who obtained a complete response (CR) to treatment in one of these 2 situations:
- Complete response (CR) obtained exclusively with first-line sunitinib treatment (sunitinib CR).
- Response obtained after a period of time on treatment with sunitinib in which local treatment was also performed (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) to achieve the total macroscopic disappearance of the disease, according to the opinion of the physician responsible for the patient (CR + local treatment).
|Condition or disease|
|Carcinoma, Renal Cell|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA|
|Estimated Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Subjects with reported metastatic renal cell carcinoma
The subjects have been treatment with sunitinib and they reached complete remission
- Percentage of patients in good, intermediate and poor prognosis who achieve complete response in the investigator´s opinion or at least 2 consecutive CT scans [ Time Frame: Between 2007 and 30 september 2018 ]Associations between complete response from a clinical point of view and the baseline characteristics of both the patient and the tumour
- Percentage of patients who achieve a complete response with previous nephrectomy [ Time Frame: Between 2007 and 30 September 2018 ]Association between complete response and nephrectomy
- Percentage of patients who achieve a complete response with clear cell histology, cromophobe, papilar I and II, and clear cell with sarcomatoid characteristics (%) [ Time Frame: Between 2007 and 30 September 2018 ]Association between complete response to sunitinib and tumour histology.
- The median time on treatment with sunitinib until lesion complete remission is reached [ Time Frame: From treatment initiation to complete remission(Between 2007 and 30 September 2018) ]
- The median duration of complete response (CR) [ Time Frame: Disease relapse to disease progression (from 3 month on treatment to 11 years) ]
- Recurrence-free Survival [ Time Frame: Baseline up to recurrence or death (from 9 months until progression or 11 years) ]
- Response duration and dose/schedule distribution [ Time Frame: From treatment initiation to 30 September 2018 ]
- Percentage of patients who received local treatment [ Time Frame: From 2007 to 30 September 2018 ]
- Percentage of adverse events of discontinuation due to sunitinib toxicity [ Time Frame: From treatment initiation to complete remission(Between 2007 and 30 September 2018) ]
- Percentage of toxicity to sunitinib in higher grade [ Time Frame: From treatment initiation to 30 September 2018 ]
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): NCT03916458
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|