Inoperable Disease, Kidney Neoplasm, Renal Cancer, SABR, SBRT
Conditions
Keywords
Stereotactic Body Radiotherapy, Renal Cancer, Primary Localized Renal Cancer, Kidney Neoplasm, Radiotherapy, Inoperable Cancer, Stereotactic ablative radiotherapy, SBRT, SABR
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.
Interventions
RADIATIONSBRT
Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.
Sponsors
Consorci Sanitari de Terrassa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local relapse-free survival | Participants should be followed continuously during 5 years | Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastases-Free Survival | Participants should be followed continuously during 5 years | Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan |
| Overall Survival | Participants should be followed continuously during 5 years | Defined as the time from diagnose to the date of death from any cause. |
| Cancer Specific Survival | Participants should be followed continuously during 5 years | Defined as the time from diagnose to the date of death from renal cancer. |
| Renal treatment-related adverse events | Participants should be followed continuously during 5 years | Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate |
| Non-Renal treatment-related adverse events | Participants should be followed continuously during 5 years | Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0 |
Countries
Spain
Outcome results
None listed