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

December 31, 2020 updated by: L.G.W. Kerkmeijer, UMC Utrecht
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: The standard treatment of RCC is (partial-) nephrectomy. Alternatives to this treatment are less invasive techniques like radio frequency ablation (RFA) and cryoablation (CA). Stereotactic body radiation therapy (SBRT) is an alternative curative treatment modality, which has shown promising results in several North-American phase I-II studies over the last years. In this study, we aim to evaluate the safety and feasibility of SBRT for patients with inoperable RCC on a conventional cone beam computed tomography (CBCT) linear accelerator.

Objective: To evaluate safety and feasibility of stereotactic body radiation therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).

Study design: Single arm prospective study. Study population: Inoperable patients ≥ 18 years, with a pathology proven RCC fulfilling the inclusion criteria.

Intervention: 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 (CT)-scan and a contrast enhanced MRI-scan. Fiducial markers will be used as this increases visibility of the tumor and therefore the accuracy of radiotherapy, particularly the irradiated healthy kidney tissue will be diminished by using this approach. Baseline toxicity and quality of life will be assessed.

SBRT using a VMAT technique will be delivered in five fractions of 7 Gy every other day. The target volume for treatment is defined on a 4D planningCT and MRI and the tumor is treated in the midposition of the breathing cycle. After treatment, follow-up will be at 1, 3, 6 and 12 months at the Radiotherapy department, followed by standard follow-up by the urologist. An additional contrast enhanced MRI scan will be performed after the 2nd treatment fraction, and after 6 and 12 months to assess treatment response to prepare for future MR-guided (MR-linac) radiotherapy. Toxicity and quality of life will be assessed during follow-up.

Main study parameters/endpoints: 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 <15% of the patients (=5 patients) report a toxicity ≤ grade 3.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARREST-study
SBRT renal cell carcinoma 5 times 7Gy
Radiation: ARREST-study
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment related adverse events grade >2 as assessed by CTCAE v.4.0
Time Frame: Within 90 days after radiotherapy
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiological response
Time Frame: 5 years after radiotherapy
Radiological treatment response of the tumor, measured according to the RECIST criteria, in combination with functional imaging parameters (multiparametric MRI).
5 years after radiotherapy
Number of participants with correlation of functional MRI (DCE and DWI) changes during treatment and radiological response after treatment
Time Frame: 12 months after radiotherapy
Response prediction (contrast enhanced MRI during treatment, after 2nd fraction)
12 months after radiotherapy
Disease specific survival
Time Frame: 5 years after radiotherapy
Disease specific survival
5 years after radiotherapy
Acute and late toxicity
Time Frame: 5 years after radiotherapy
Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
5 years after radiotherapy
Quality of life questionnaire
Time Frame: 12 months after radiotherapy
EORTC-QLQ-C30
12 months after radiotherapy
Overall survival
Time Frame: 5 years after radiotherapy
Overall survival
5 years after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UMC Utrecht

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: L GW Kerkmeijer, MD, PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL55770.041.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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