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.
Study Type
OBSERVATIONAL
Enrollment
53
high dose radiation in few fractions
Humanitas PIO X
Milan, Milan, Italy
NOT_YET_RECRUITINGIrccs Humanitas Research Hospital
Rozzano, Milan, Italy
RECRUITINGevaluate 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
Time frame: from end of treatment to 1 year
to assess acute and late toxicity
evaluate the presence of toxicities to treatment according to CTCAE 4.03
Time frame: from start of treatment to 3 years
To assess kidney function with serum creatinine
evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)
Time frame: from start of treatment to 3 years
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
Time frame: from end of treatment to 1 year
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
Time frame: from end of treatment to 3 years
Overall Survival
to asses through standard imaging according to clinical practice - The length of time from the start of cancer treatment during which patients diagnosed with the disease are still alive.
Time frame: from end of treatment to 3 years
To asses Quality of Life
Through QLQ-C30 questionnarie we will evaluate quality of life, patient will answer different questions crossing the number that is more suitable regarding their condition (the patient can respond by crossing a number from 1 to 4, 1 = excellent quality of life, 4 = terrible quality of life)
Time frame: from start of treatment to 3 years
To assess kidney function with estimated glomerular filtration rate
evaluating eGFR at each follow up visit through blood analysis (ml/min)
Time frame: from start of treatment to 3 years
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