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NCT Number: NCT07299357

Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial

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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Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas PIO X, Milan, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • ECOG performance status 0 - 2
  • Histologically confirmed diagnosis of primary RCC
  • cT1 stage tumor with single lesion with maximum diameter of 7 cm
  • Medically inoperable or at high risk of complication from surgery, or declined surgery
  • Absence of metastatic disease
  • Written informed consent

Exclusion criteria

  • Estimated glomerular filtration rate (eGFR) < 30 mls/min
  • Previous radiotherapy on the same site
  • Previous systemic therapy for RCC
  • Tumor diameter larger than 7 cm
  • Presence of metastatic disease
  • Life expectancy < 3 months

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

high dose radiation in few fractions

Primary outcomes

  1. evaluate LC of treated lesions at 1 year

    Time frame: from end of treatment to 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

Secondary outcomes

  1. to assess acute and late toxicity

    Time frame: from start of treatment to 3 years

    evaluate the presence of toxicities to treatment according to CTCAE 4.03

  2. To assess kidney function with serum creatinine

    Time frame: from start of treatment to 3 years

    evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)

  3. Progression Free Survival (PFS)

    Time frame: from end of treatment to 1 year

    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

  4. metastasis free survival

    Time frame: from end of treatment to 3 years

    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

  5. Overall Survival

    Time frame: from end of treatment to 3 years

    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.

  6. To asses Quality of Life

    Time frame: from start of treatment to 3 years

    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)

  7. To assess kidney function with estimated glomerular filtration rate

    Time frame: from start of treatment to 3 years

    evaluating eGFR at each follow up visit through blood analysis (ml/min)

Study contacts

Contact information is provided by the study sponsor or research team.

Ciro Franzese, MD, radiation oncologist

CONTACT

[email protected]

+39 0282247454

Laura Bonavita, Master's degree

CONTACT

[email protected]

+390282247026

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2033
First posted
Dec 23, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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