Clinical trial · Interventional
Ablative tReatment of Inoperable REnal Cell Carcinoma Using STereotactic Body Radiotherapy (ARREST-study)
NCT02853162CI-TRIAL-00049228ARRESTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow inclusion
Summary
Brief summary (as posted)
Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARREST-study | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARREST-study
- description
- SBRT renal cell carcinoma 5 times 7Gy
- interventionNames
- Radiation: ARREST-study
Primary outcomes (1)
- measure
- Number of participants with treatment related adverse events grade >2 as assessed by CTCAE v.4.0
- timeFrame
- Within 90 days after radiotherapy
- description
- The treatment is considered successful if all 5 treatments are completed and if in total \<15% of the patients (=5 patients) report an acute toxicity ≤ grade 3
Secondary outcomes (6)
- measure
- Radiological response
- timeFrame
- 5 years after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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: * 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 \< 3 weeks before treatment; * Targeted therapy (sunitinib, etc.) ≤ 7 days before treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.