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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | high dose radiation in few fractions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from end of treatment to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| to assess acute and late toxicity | evaluate the presence of toxicities to treatment according to CTCAE 4.03 | from start of treatment to 3 years |
| To assess kidney function with serum creatinine |
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Inclusion Criteria:
Exclusion Criteria:
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patient with renal cancer not candidate to surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ciro Franzese, MD, radiation oncologist | Contact | +39 0282247454 | ciro.franzese@hunimed.eu | |
| Laura Bonavita, Master's degree | Contact | +390282247026 | laura.bonavita@humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas PIO X | Not yet recruiting | Milan | Milan | 20159 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38423047 | Background | Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2. | |
| 36400098 |
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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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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)
| from start of treatment to 3 years |
| 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 | from end of treatment to 1 year |
| 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 | from end of treatment to 3 years |
| Overall Survival | to asses through standard imaging according to clinical practice - The length of time from the start of cancer treatment during which patients diagnosed with the disease are still alive. | from end of treatment to 3 years |
| To asses Quality of Life | Through QLQ-C30 questionnarie we will evaluate quality of life, patient will answer different questions crossing the number that is more suitable regarding their condition (the patient can respond by crossing a number from 1 to 4, 1 = excellent quality of life, 4 = terrible quality of life) | from start of treatment to 3 years |
| To assess kidney function with estimated glomerular filtration rate | evaluating eGFR at each follow up visit through blood analysis (ml/min) | from start of treatment to 3 years |
| Irccs Humanitas Research Hospital | Recruiting | Rozzano | Milan | 20089 | Italy |
|
| Background |
| Siva S, Ali M, Correa RJM, Muacevic A, Ponsky L, Ellis RJ, Lo SS, Onishi H, Swaminath A, McLaughlin M, Morgan SC, Cury FL, Teh BS, Mahadevan A, Kaplan ID, Chu W, Grubb W, Hannan R, Staehler M, Warner A, Louie AV. 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Lancet Oncol. 2022 Dec;23(12):1508-1516. doi: 10.1016/S1470-2045(22)00656-8. Epub 2022 Nov 16. |
| Background | AIOM-AIRTUM. I numeri del cancro in Italia. Rapporto 2020. Disponibile sul sito: https://www.aiom.it/i-numeri-del-cancro-in-italia |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |