Ablative tReatment of Inoperable REnal Cell Carcinoma Using STereotactic Body Radiotherapy (ARREST-study)

NCT02853162 | Terminated Phase 2

• 1 other identifier: NL55770.041.15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Renal Cell Carcinoma

Keywords

Stereotactic body radiotherapy; MRI; Renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment related adverse events grade >2 as assessed by CTCAE v.4.0

  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

  Within 90 days after radiotherapy

Secondary Outcomes (6)

• Radiological response

  5 years after radiotherapy

• Number of participants with correlation of functional MRI (DCE and DWI) changes during treatment and radiological response after treatment

  12 months after radiotherapy

• Disease specific survival

  5 years after radiotherapy

• Acute and late toxicity

  5 years after radiotherapy

• Quality of life questionnaire

  12 months after radiotherapy

Study Arms (1)

ARREST-study

EXPERIMENTAL

SBRT renal cell carcinoma 5 times 7Gy

Radiation: ARREST-study

Interventions

ARREST-study RADIATION

Radiotherapy will be delivered in five fractions of 7 Gy every other day. An additional contrast enhanced MRI scan will be performed after the 2nd treatment fraction, and after 6 and 12 months

ARREST-study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Evidence of metastatic disease;
• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• L GW Kerkmeijer, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: August 2, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

NL (1)