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Trial record 1 of 1 for:    A6181227
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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 : Completed
First Posted : April 16, 2019
Results First Posted : December 13, 2021
Last Update Posted : December 13, 2021
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
Actual Enrollment : 62 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA STUDY)
Actual Study Start Date : December 17, 2019
Actual Primary Completion Date : November 3, 2020
Actual Study Completion Date : November 3, 2020


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. Time to Complete Remission of Lesions [ Time Frame: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.

  2. Duration of Complete Remission (DOR) [ Time Frame: From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.

  3. Progression Free Survival (PFS) [ Time Frame: From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months) ]
    PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.


Other Outcome Measures:
  1. Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis [ Time Frame: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities.

  2. Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans [ Time Frame: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities.

  3. Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status [ Time Frame: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.

  4. Time to Achieve CR in Participants Classified According to Histology Type [ Time Frame: From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.

  5. Duration of Response Based on Type of Treatment Received [ Time Frame: From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.

  6. Number of Participants With Dose Interruption [ Time Frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
  7. Number of Participants Who Received Subsequent Local Treatment [ Time Frame: Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant.

  8. Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity [ Time Frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.

  9. Number of Participants With Grade 3 or Higher Toxicity to Sunitinib [ Time Frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) ]
    Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Days and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Locations
Show Show 31 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] October 18, 2018
Statistical Analysis Plan  [PDF] October 29, 2019

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03916458    
Other Study ID Numbers: A6181227
ATILA ( Other Identifier: Alias Study Number )
First Posted: April 16, 2019    Key Record Dates
Results First Posted: December 13, 2021
Last Update Posted: December 13, 2021
Last Verified: October 2021
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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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