About this trial
The study objective is to evaluate the use of Stereotactic Body Radiotherapy (high dose of radiation in a few fractions) to cure primary renal cancer in those patients that are not indicated to surgery (high risk of complications, refusal of the patient). This therapy is already used in clinical setting for many tumors with good tolerance as it is not invasive, does not require anesthesia and hospitalization making it suitable for elderly people and frail patients. However there are not enough information regarding the use of ablative doses for the cure of renal cancer and for this reason this study aims to support the use of Stereotactic Body Radiotherapy as a standard of care for inoperable primary renal tumor. This is an observational study, so it collects data from clinical pratice only and does not request study specific procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
ECOG performance status 0 - 2
Histologically confirmed diagnosis of primary RCC
cT1 stage tumor with single lesion with maximum diameter of 7 cm
Disqualifiers
Estimated glomerular filtration rate (eGFR) < 30 mls/min
Previous radiotherapy on the same site
Previous systemic therapy for RCC
Tumor diameter larger than 7 cm
Trial population
patient with renal cancer not candidate to surgery
Trial design
Cohort
Prospective
Treatments tested in this trial
Stereotactic body radiotherapy (SBRT)
Radiationhigh dose radiation in few fractions
Treatment groups
Trial outcomes
Primary outcomes
evaluate LC of treated lesions at 1 year
local progression is defined as an enlargement of at least 20% relative and 5 mm absolute increase of sum of diameters of target lesions compared to baseline at least after 6 months from treatment end
Secondary outcomes
to assess acute and late toxicity
evaluate the presence of toxicities to treatment according to CTCAE 4.03
To assess kidney function with serum creatinine
evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)
Progression Free Survival (PFS)
to asses through standard imaging according to clinical practice - The length of time during and after the treatment of cancer that a patient lives with the disease but it does not get worse
metastasis free survival
to asses through standard imaging according to clinical practice - The length of time from the start of treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body
Sponsors and contacts
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