Stereotactic MR-Adaptive Radiation Therapy for Early-stage Renal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

The purpose of this study is to investigate the use of an MR-guided linear accelerator to treat early stage renal cancer patients, considered inoperable or in patients declining surgerys. The study will collect efficacy, toxicity, and dosimetry data and assess the degree of improvement provided by this treatment technique. The primary objective is to evaluate whether magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) for primary renal cancer has an improved toxicity profile relative to conventional computed tomography (CT) based radiation therapy, as measured by the frequency of grade 2+ adverse events following MRgRT as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients at or over 18 years old.

Patients may enter the study if they are diagnosed with bilateral kidney cancer, recurrent kidney cancer, or if they have previous or current history of a another primary cancer, given all other inclusion criteria met.

Have a pathologically confirmed diagnosis of renal cell carcinoma (RCC) of any histology, or radiographic diagnosis if biopsy is not clinically indicated, consistent with standard clinical practice where imaging findings provide sufficient diagnostic certainty. In such cases, biopsy may not be required to avoid additional procedural risk; however, inclusion of patients without histologic confirmation may introduce some diagnostic uncertainty, which will be considered in the interpretation of study results.

Patients must be deemed a suboptimal surgical or ablation candidate, as determined by the patient's primary urologist at NYU Langone Health and confirmed by multidisciplinary consensus, or may be individuals who decline surgery or ablation following appropriate clinical evaluation and discussion..

Disqualifiers

An MRI contraindication (e.g. severe claustrophobia or MRI-incompatible device). In the event of mild claustrophobia, patients will be permitted to take anti-anxiety medication as required for simulation and treatment.

A pre-treatment estimated glomerular filtration rate < 30 cc/min.

Visceral, nodal, or bony metastatic disease.

Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI-guided linear accelerator

    Device

    MRI images are obtained before treatment, for adaptive planning, as well as in real-time, to allow for motion monitoring and respiratory gating.

  • Magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT)

    Radiation

    The patients will be treated using an MR-guided approach with adaptive online replanning and respiratory gating using an Elekta Unity MR linac system. Stereotactic Body Radiotherapy (SBRT) will be delivered with a prescription dose of 26Gy in 1 fraction to the PTV\_26 volume as defined by MR imaging.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Early stage renal cancerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of grade 2 or higher toxicity events

Determined as the frequency of grade 2+ adverse events following treatment as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.

Time frame
Up to 12 months after completion of treatment

Secondary outcomes

1

Change in glomerular filtration rate

Time frame
Baseline, Month 12
2

Number of treatment related toxicities

This will provide a broader perspective of toxicity by including the Grade 1 toxicities, relative to the primary endpoint.

Time frame
Up to 12 months after completion of treatment
3

Progression free survival

PFS is defined as the time from initiation of treatment to disease progression or death from any cause.

Time frame
Month 12
4

Distant metastasis-free survival

Defined as the length of time after treatment that a patient lives without the cancer spreading to distant organs or parts of the body.

Time frame
Month 12

Other outcomes

Sponsors and contacts

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