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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

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).

Condition or disease
Carcinoma, Renal Cell

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Subjects with reported metastatic renal cell carcinoma
The subjects have been treatment with sunitinib and they reached complete remission



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. The median duration of complete response (CR) [ Time Frame: Disease relapse to disease progression (from 3 month on treatment to 11 years) ]
  3. Recurrence-free Survival [ Time Frame: Baseline up to recurrence or death (from 9 months until progression or 11 years) ]
  4. Response duration and dose/schedule distribution [ Time Frame: From treatment initiation to 30 September 2018 ]
  5. Percentage of patients who received local treatment [ Time Frame: From 2007 to 30 September 2018 ]
  6. Percentage of adverse events of discontinuation due to sunitinib toxicity [ Time Frame: From treatment initiation to complete remission(Between 2007 and 30 September 2018) ]
  7. Percentage of toxicity to sunitinib in higher grade [ Time Frame: From treatment initiation to 30 September 2018 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03916458     History of Changes
Other Study ID Numbers: A6181227
ATILA ( Other Identifier: Alias Study Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Carcinoma, Renal Cell
Disease-Free Survival
Sunitinib
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Prognosis
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action