REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

Completed

• Conditions: Carcinoma, Renal Cell

• Registration Number: NCT03916458
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-12-17
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Status Verified: 2021-10
• Results First Submitted: 2021-10-29
• Results First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Results First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Complete Remission of Lesions	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.
Duration of Complete Remission (DOR)	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.
Progression Free Survival (PFS)	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.

Trial Locations

Locations (31)

Hospital Duran i Reynals; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma de Mallorca, Mallorca, Spain

Hospital Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Tenerife, Spain

Complexo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Hospital Universitario Doctor Peset; 🇪🇸 València, Spain

Hospital San Juan de Dios; 🇪🇸 Manresa, Barcelona, Spain

Hospital Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain

Hospital Universitario Mutua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcon, Madrid, Spain

Complexo Hospitalario Universitario de Ferrol; 🇪🇸 A Coruña, Spain

Hospital Universitario de Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Clínico San Carlos de Madrid; 🇪🇸 Madrid, Spain

Hospital Infanta Cristina; 🇪🇸 Parla, Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospita Virgen de la Salud; 🇪🇸 Toledo, Madrid, Spain

Hospital Universitario Lucus Augusti / Servicio de Oncología Médica; 🇪🇸 Lugo, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Complejo Asistencial de Segovia; 🇪🇸 Segovia, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital de la Santa Creu i Sant; 🇪🇸 Barcelona, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Clínico de Barcelona; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain