Clinical trial · Observational
REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA STUDY)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Subjects with reported metastatic renal cell carcinoma
- description
- The subjects have been treatment with sunitinib and they reached complete remission
Primary outcomes (3)
- 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)
- description
- 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.
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Days
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDde 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. PMID 36610891