Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Local relapse-free survival
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Local relapse-free survival
Time Frame: Participants should be followed continuously during 5 years
Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Secondary Outcomes
- Overall Survival(Participants should be followed continuously during 5 years)
- Cancer Specific Survival(Participants should be followed continuously during 5 years)
- Renal treatment-related adverse events(Participants should be followed continuously during 5 years)
- Metastases-Free Survival(Participants should be followed continuously during 5 years)
- Non-Renal treatment-related adverse events(Participants should be followed continuously during 5 years)
Investigators
Manuel Galdeano-Rubio
Radiation Oncologist, MD, MSc
Consorci Sanitari de Terrassa