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Ablative tReatment of inoperable REnal cell carcinoma using STereotactic body Radiotherapy

Ablative tReatment of inoperable REnal cell carcinoma using STereotactic body Radiotherapy - ARREST

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46152
Enrollment
30
Registered
2016-03-30
Start date
2016-09-22
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney cancer Renal cell carcinoma

Interventions

Prior to treatment, patients will undergo fiducial marker placement (in combination with a biopsy, if RCC has not been pathology proven), followed by a contrast enhanced planning computed tomography

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Inoperability, or when a patient refuses surgery (i.e. not eligible for (partial-) nephrectomy or RFA); - Kidney function allows for intervention, as evaluated by treating urologist (taking into account eGFR and renogram); - Age * 18 years; - Written informed consent; - Diagnosis of RCC confirmed by pathology (in case determined after informed consent, patients who are not eligible anymore (no RCC) will be excluded).

Exclusion criteria

Exclusion criteria: - Evidence of metastatic disease; - Exclusion criteria for contrast enhanced MRI scan, according to the protocol of the department of Radiology, UMC Utrecht; - Patients with one functioning kidney; - Prior renal surgery (partial nephrectomy); - Prior radiotherapy on upper abdomen; - Unsafe to have fiducial marker implantation: i.e. anticoagulant agents use other than acetylsalicyl acid, which cannot be safely stopped/bridged for implantation; - WHO * 3; - Chemotherapy

Design outcomes

Primary

MeasureTime frame
Newly developed acute toxicity grade 3 or more according to the Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0. The treatment is considered successful if all 5 treatments are completed and if in total

Secondary

MeasureTime frame
Secondary endpoints will be treatment response, (late) toxicity assessment, local control rate and quality of life assessment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)