To evaluate safety and feasibility of stereotactic body radiation therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).The treatment is considered successful if all 5 treatments are completed and if in total
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal disorders (excl nephropathies)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary endpoints will be treatment response, (late) toxicity assessment,
local control rate and quality of life assessment.
Background summary
The incidence of renal cell carcinoma (RCC) is increasing due to the increased
use of diagnostic imaging. 60-70% of the RCC are incidentaloma*s, often
classified as small renal masses (SRM). The standard treatment of RCC is
(partial-) nephrectomy. Alternatives to this treatment are less invasive
techniques like radio frequency ablation (RFA) and cryoablation (CA). So far,
only these invasive treatments of RCC has been shown to be curative. An
alternative curative treatment option (completely non-invasive or with the use
of fiducial markers) is stereotactic body radiation therapy (SBRT), which has
shown promising results in Toronto 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.
Study objective
To evaluate safety and feasibility of stereotactic body radiation therapy
(SBRT) with fiducial markers in inoperable patients with renal cell carcinoma
(RCC).
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.
Study design
Single arm prospective study.
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.
Radiotherapy will be delivered in five fractions of 7 Gy every other day. 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 (+/- 14 days) and 12 (+/- 14 days) months to assess treatment
response. Toxicity and quality of life will be assessed during follow-up.
Study burden and risks
The treatment in this study will be the same as the standard SBRT treatment
currently used at Sunnybrook Hospital (Odette Cancer Centre in Toronto) for
patients with inoperable RCC, except for the planning MRI, the MRI after the
2nd radiotherapy fraction and after 6 months (+/- 14 days) and 12 months (+/-
14 days). The same dose fractionation scheme and dose constraints for the
healthy tissues will be used. In addition, placement of fiducial markers will
take place to target the tumor prior to each treatment fraction. Quality of
life and toxicity will be assessed until 12 months after treatment, followed by
standard follow-up by the urologist.
A potential benefit of this study is that it allows for a curative intent
treatment for patients with inoperable RCC in a population with otherwise no
perspective on a curative treatment.
We don*t think severe (grade 3 or higher) toxicity resulting from SBRT
treatment will occur in most patients (when adhering to the healthy tissue dose
constraints) based on previous (although with limited follow-up) SBRT study
results. The placement of fiducial markers (and if not previously performed
also the biopsy), may potentially cause infection and bleeding.
Moreover, this study is a required step in the development of MRI-guided
radiotherapy for operable and inoperable patients in the future.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02853162 |
| CCMO | NL55770.041.15 |