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Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Localized Renal Cancer-One arm | Patients diagnosed with medically inoperable localized renal cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local relapse-free survival | Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan | Participants should be followed continuously during 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metastases-Free Survival | Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan | Participants should be followed continuously during 5 years |
| Overall Survival | Defined as the time from diagnose to the date of death from any cause. |
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Inclusion Criteria:
Exclusion criteria:
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Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Galdeano-Rubio, MD | Consorci Sanitari de Terrassa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Participants should be followed continuously during 5 years |
| Cancer Specific Survival | Defined as the time from diagnose to the date of death from renal cancer. | Participants should be followed continuously during 5 years |
| Renal treatment-related adverse events | Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate | Participants should be followed continuously during 5 years |
| Non-Renal treatment-related adverse events | Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0 | Participants should be followed continuously during 5 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |