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

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA STUDY)

ClinicalTrials.gov ID

NCT03916458

Acronym / sponsor ID

ATILA / A6181227

Conditions

Carcinoma, Renal Cell

Keywords

Carcinoma, Renal Cell, Disease-Free Survival, Sunitinib, Protein Kinase Inhibitors, Angiogenesis Inhibitors, Prognosis

Study type

Observational

Recruitment status

Completed

Enrolment

62 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

17 Dec 2019 (actual)

Primary completion

3 Nov 2020 (actual)

Study completion

3 Nov 2020 (actual)

First posted

16 Apr 2019 (actual)

Results

Posted 13 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Other

Time perspective

Retrospective

Number of arms

1

Who may qualify

Ages

18 days and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36610891de Velasco G, Alonso-Gordoa T, Rodriguez-Vida A, Anguera G, Campayo M, Pinto A, Ortega EM, Gallardo E, Nunez NF, Garcia-Carbonero I, Reig O, Mendez-Vidal MJ, Fernandez-Calvo O, Cassinello NV, Torregrosa D, Lopez-Martin A, Rosero A, Valiente PG, de Espana CG, Climent MA, Santasusana MD, Sanchez AR, Gonzalez IC, Afonso R, Garcia Del Muro X, Casinello J, Fernandez-Parra EM, Garcia Sanchez L, Afonso J, Polo SH, Asensio U. Long-term Clinical Outcomes of a Spanish Cohort of Metastatic Renal Cell Carcinoma Patients with a Complete Response to Sunitinib. Clin Genitourin Cancer. 2023 Jun;21(3):e166-e174. doi: 10.1016/j.clgc.2022.11.021. Epub 2022 Dec 5.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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.

Related trials for Carcinoma, Renal Cell

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• Active, not recruitingPhase 3

  A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

  Carcinoma, Renal Cell

• RecruitingPhase 2/3

  Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

  Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

• Not yet recruitingPhase 2

  Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer

  Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma

• Not yet recruitingPhase 2

  Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma

  Localized Clear Cell Renal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

31 sites in 1 country: see every site and its status.