Clinical trial NCT03916458: 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 (ATILA STUDY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Carcinoma, Renal Cell
Disease-Free Survival
Sunitinib
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Prognosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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)

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).


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.

Primary outcomes:
measure: Time to Complete Remission of Lesions
timeFrame: 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)
measure: Duration of Complete Remission (DOR)
timeFrame: 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)
measure: Progression Free Survival (PFS)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
measure: Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis
timeFrame: 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)
measure: Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans
timeFrame: 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)
measure: Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status
timeFrame: 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)
measure: Time to Achieve CR in Participants Classified According to Histology Type
timeFrame: 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)
measure: Duration of Response Based on Type of Treatment Received
timeFrame: 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)
measure: Number of Participants With Dose Interruption
timeFrame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
measure: Number of Participants Who Received Subsequent Local Treatment
timeFrame: Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
measure: Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity
timeFrame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
measure: Number of Participants With Grade 3 or Higher Toxicity to Sunitinib
timeFrame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Manresa
country: Spain
facility: Hospital San Juan de Dios
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario de Marqués de Valdecilla
state: Cantabria
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Parla
country: Spain
facility: Hospital Infanta Cristina
state: Madrid
city: Toledo
country: Spain
facility: Hospita Virgen de la Salud
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Mallorca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
state: Tenerife
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de Ferrol
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant
city: Barcelona
country: Spain
facility: Hospital Clínico de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti / Servicio de Oncología Médica
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Segovia
country: Spain
facility: Complejo Asistencial de Segovia
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: València
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: