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Trial record 1 of 1 for:    NCT03916458
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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 12, 2019
First Posted Date April 16, 2019
Last Update Posted Date April 16, 2019
Estimated Study Start Date April 18, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 12, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
Official Title REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
Brief Summary

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:

  1. Complete response (CR) obtained exclusively with first-line sunitinib treatment (sunitinib CR).
  2. 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patient population eligible for this study includes any patient with advanced or metastatic renal cell cancer who has been treated with Sunitinib and has achieved CR of the tumour and its metastases at any time during treatment and according to the usual assessment criteria in daily clinical practice, whether it was obtained with sunitinib alone or if a local treatment was needed to eradicate all the lesions: (surgery of the residual metastases, radiofrequency ablation or radiotherapy)
Condition Carcinoma, Renal Cell
Intervention Not Provided
Study Groups/Cohorts Subjects with reported metastatic renal cell carcinoma
The subjects have been treatment with sunitinib and they reached complete remission
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 12, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 September 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. This response must have been reached through two possible strategies:

    A) Systemic treatment with sunitinib alone. B) Treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, SBRT (Stereotactic Body Radiation Therapy)).

  2. The duration of CR must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. Although the patient had progressed subsequently, he/she may be included in this registry.
  3. Patients from any risk group
  4. Tumours of any histology

Exclusion Criteria:

  1. Patients treated with another drug other than Sunitinib.
  2. Patients with no radiology reports proving CR.
  3. Patients with no record of the dose and regimen received with Sunitinib.
  4. Patients who achieved complete remission after 30 September 2018.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03916458
Other Study ID Numbers A6181227
ATILA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019