Clinical trial NCT05817604: Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
Official title: Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Neoplasm
Renal Cancer
Inoperable Disease
SBRT
SABR
Keywords: Stereotactic Body Radiotherapy
Renal Cancer
Primary Localized Renal Cancer
Kidney Neoplasm
Radiotherapy
Inoperable Cancer
Stereotactic ablative radiotherapy
SBRT
SABR
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers

Brief summary: Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer

Detailed description: Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer.

Participants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme.

Assesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

Follow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET.
* Tumor Diameter \>1cm - \<7cm
* Tumor visible on CT planning
* Medically inoperable disease (or rejection of surgery)
* Karnofsky Index \>70%
* \>18 y.o.
* Informed Consent signature

Exclusion criteria:

* Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy.
* Previous local/regional RT
* Life expectancy \<6 months
* Concomitance with other antineoplastic drugs

Primary outcomes:
measure: Local relapse-free survival
timeFrame: Participants should be followed continuously during 5 years
Secondary outcomes:
measure: Metastases-Free Survival
timeFrame: Participants should be followed continuously during 5 years
measure: Overall Survival
timeFrame: Participants should be followed continuously during 5 years
measure: Cancer Specific Survival
timeFrame: Participants should be followed continuously during 5 years
measure: Renal treatment-related adverse events
timeFrame: Participants should be followed continuously during 5 years
measure: Non-Renal treatment-related adverse events
timeFrame: Participants should be followed continuously during 5 years
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Manuel Galdeano-Rubio, MD
role: PRINCIPAL_INVESTIGATOR
References: