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

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ClinicalTrials.gov Identifier: NCT02853162
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
L.G.W. Kerkmeijer, UMC Utrecht

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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: ARREST-study Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablative tReatment of Inoperable REnal Cell Carcinoma Using STereotactic Body Radiotherapy (ARREST-study)
Study Start Date : June 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. Disease specific survival [ Time Frame: 5 years after radiotherapy ]
    Disease specific survival

  4. Acute and late toxicity [ Time Frame: 5 years after radiotherapy ]
    Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0

  5. Quality of life questionnaire [ Time Frame: 12 months after radiotherapy ]
    EORTC-QLQ-C30

  6. Overall survival [ Time Frame: 5 years after radiotherapy ]
    Overall survival



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853162


Contacts
Contact: L GW Kerkmeijer, MD, PhD +31887553039 L.Kerkmeijer@umcutrecht.nl
Contact: F M Prins, MD +31887553039 F.M.Prins-2@umcutrecht.nl

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: L GW Kerkmeijer, MD, PhD         
Contact: F M Prins, MD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: L GW Kerkmeijer, MD, PhD UMC Utrecht

Responsible Party: L.G.W. Kerkmeijer, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02853162     History of Changes
Other Study ID Numbers: NL55770.041.15
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by L.G.W. Kerkmeijer, UMC Utrecht:
Stereotactic body radiotherapy
MRI
Renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases