Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological or clinical diagnosis of primary or secondary kidney tumors
Patients aged ≥18 years
Signed informed consent
Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)
Disqualifiers
Patients aged < 18 years
Tumors > 10 cm
PS ECOG ≥3
Psychiatric or other disorders that may prevent the patient from signing informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic body radiotherapy (SBRT)
RadiationSBRT for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (according to tumor size), using CyberKnife
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute toxicity
Acute toxicity grade ≥2 as the maximum toxicity value at 3 months after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Time frame
3 months2
Late toxicity
Late toxicity grade ≥2 as the maximum toxicity value at 3 years after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Time frame
3 yearsSecondary outcomes
1
Local control of the treated lesion (LC)
Local control of the treated site expressed in terms of local recurrence rate
Time frame
3 years2
Local Relapse-Free Survival (time to local recurrence, LRFS)
From the date of radiotherapy end until the date of local relapse, assessed up to 3 years
Time frame
3 years3
Regional Relapse-Free Survival (RRFS)
From the date of radiotherapy end until the date of regional relapse, assessed up to 3 years
Time frame
3 years4
Distant Metastases-Free Survival (DMFS)
From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 3 years
Time frame
3 yearsOther outcomes
1
Incidence of Treatment-Emergent Adverse Events as assessed with tumor specific quality of life questionnaires
Quality of life (QoL) related to treatment using the European Organisation for Research and Treatment of Cancer (EORTC) Italian version of quality-of-life core QLQ-C30 questionnaire completed before treatment, at the end of treatment, and at 1, 3, 6, 12, 18, 24, 36 months after SBRT.
Time frame
3 years2
Organ motion
Modeling of organ movement during treatment
Time frame
Perioperative/periprocedural3
Clinical and dosimetric prognostic factors
Identification of clinical, imaging, and laboratory prognostic factors for an aggressive phenotype of kidney cancer and for toxicity.
Time frame
3 years4
Radiomics
Evaluation of radiomic characteristics: Mathematical extraction of the spatial distribution of signal intensities and pixel interrelationships of medical images of the patients, to quantify textural information resampled according to International Biomarker Standardization Initiative (IBSI).
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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