Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial

ConditionRenal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    high dose radiation in few fractions

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
from end of treatment to 1 year

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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