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Trial registered on ANZCTR


Registration number
ACTRN12610000690055
Ethics application status
Approved
Date submitted
16/08/2010
Date registered
20/08/2010
Date last updated
12/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with Renal cell carcinoma (STX0110).
Scientific title
Pilot study of Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with Renal cell carcinoma.
Secondary ID [1] 252451 0
None
Universal Trial Number (UTN)
Trial acronym
RESIRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 257962 0
Condition category
Condition code
Cancer 258130 258130 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study that will be the first in human study to evaluate the feasibility, safety,
toxicity and potential effectiveness of selective internal radiation therapy (SIRT) using SIR-Spheres
microspheres as a treatment for patients with renal cell carcinoma that is not suitable
for curative therapy by conventional means.
Patients will be serially recruited into dose escalating cohorts: 75Gy, 100Gy, 150Gy, 200Gy, 300Gy intended radiation dose to the tumour. If no dose limiting toxicity is evident following completion of recruitment into the 300Gy cohort, then a final cohort of six patients may be recruited. In this final cohort, the angiographic endpoint of “imminent stasis” in the renal artery will serve as the endpoint for delivery of SIR-Spheres microspheres, regardless of actual dose delivered.
Intervention code [1] 257017 0
Treatment: Devices
Comparator / control treatment
Patients will be recruited serially into six cohorts: 75Gy, 100Gy, 150Gy, 200Gy, 300Gy intended radiation dose to tumour and 'imminent stasis'.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258994 0
Safety and toxicity will be assessed using the National Cancer Institute Common Terminology Criteria (NCICTC) version 4.0.
Timepoint [1] 258994 0
30 post-SIRT
Secondary outcome [1] 265197 0
Tumour Response (Response will be calculated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria).
Timepoint [1] 265197 0
12 Months post-SIRT
Secondary outcome [2] 265198 0
Progression-free survival (PFS) is defined as the time interval between study entry and the
date of tumour progression. Tumour progression in the kidney is determined from serial 3 monthly magnetic resonance imaging (MRI) scans.
Timepoint [2] 265198 0
12 Months post-SIRT
Secondary outcome [3] 265199 0
Overall survival (OS) is defined as the time interval between the date of study entry and the date of
death.
Timepoint [3] 265199 0
12 months post-SIRT
Secondary outcome [4] 265200 0
Quality of life will be measured by using a renal cell carcinoma specific questionnaire
(Harding 2007) and will be assessed at baseline, 30 days post-SIRT and
then at 3 month intervals for the first 12 months post-SIRT.
Timepoint [4] 265200 0
12 months post-SIRT

Eligibility
Key inclusion criteria
In order to be considered eligible for the study, patients must fulfil the following inclusion criteria:

(a) Willing, able and mentally competent to provide written informed consent.

(b) Histologically confirmed primary renal cell carcinoma of the kidney.

(c) Unequivocal and measurable MRI evidence of primary renal cell carcinoma that either:
1) is not suitable for treatment by surgical resection, local ablation or other conventional techniques with curative intent; or 2) does not require immediate treatment by surgical resection, local ablation or other conventional techniques with curative intent, at the time
of study entry.

(d) Metastatic disease other than untreated central nervous system (CNS) metastases is permitted.

(e) All imaging evidence used as part of the screening process must be less than 45 days old at the time of delivery of protocol SIRT therapy.

(f) Suitable for protocol therapy as determined by both the Medical Oncology and Surgical Urology Investigators.

(g) Other than radiotherapy, prior therapy for primary renal cell carcinoma is allowed, provided that such therapy was administered and completed at least 45 days prior to
entry into this study.

(h) World Health Organisation (WHO) performance status 0 – 2.

(i) Adequate haematological and renal function as follows:
Haematological Neutrophils > 1.5 x 109/L
Platelets > 100 x 109/L
Renal Calculated glomerular filtration rate (GFR) > 30 ml/min/1.73m2

(j) Aged 18 years or older.

(k) Female patients must be postmenopausal, or surgically sterile, or if sexually active using
an acceptable method of contraception.

(l) Male patients must be surgically sterile or if sexually active and having a pre-menopausal
female partner must be using an acceptable method of contraception.

(m) Life expectancy of at least 3 months without any active treatment.

(n) Renal arterial anatomy suitable for implantation of SIR-Spheres microspheres, as assessed by visceral and renal angiogram.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be considered ineligible for the study for any of the following reasons:

(a) Previous radiotherapy delivered to the kidney or within a 5cm margin.

(b) Subsequent therapy planned to be administered within 60 days of the delivery of protocol SIRT therapy.

(c) Renal-to-lung shunt fraction that indicates potential exposure to the lung to an absorbed radiation dose of more than 25Gy.

(d) Inadequate renal function as defined by estimated GFR <30 ml/min/1.7m2.

(e) Intercurrent disease that would render the patient unsuitable for treatment according to this protocol.

(f) Equivocal, immeasurable, or unevaluable primary renal cell carcinoma in the kidney.

(g) Pregnant or breast feeding.



Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients will be recruited serially into six cohorts: 75Gy, 100Gy, 150Gy, 200Gy, 300Gy intended radiation dose to tumour and imminent stasis
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257469 0
Commercial sector/Industry
Name [1] 257469 0
Sirtex Technology Pty Ltd
Address [1] 257469 0
Level 33, 101 Miller Street, North Sydney, NSW, 2060
Country [1] 257469 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sirtex Technology Pty Ltd
Address
Level 33, 101 Miller Street, North Sydney, NSW, 2060
Country
Australia
Secondary sponsor category [1] 256737 0
None
Name [1] 256737 0
Address [1] 256737 0
Country [1] 256737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259495 0
Ethics committee address [1] 259495 0
Ethics committee country [1] 259495 0
Australia
Date submitted for ethics approval [1] 259495 0
Approval date [1] 259495 0
20/07/2010
Ethics approval number [1] 259495 0

Summary
Brief summary
The treatment known as selective internal radiation therapy, or SIRT has been used in human patients since 1998 for the treatment of liver cancer.

This study will be the first time that SIRT treatment has been used in human patients for the treatment of kidney cancer. The primary purpose of this study is to test the safety of SIRT as a treatment for patients with kidney cancer (also known as renal cell carcinoma) that is not suitable for treatment using the standard treatment options available.

While SIRT treatment has been used for over a decade to treat liver cancer, it has not been used before to treat kidney cancer. In this study, four separate groups of patients will be entered into the study. The four groups of patients will each receive a certain dose of selective internal radiation therapy for their kidney cancer. The dose of radiation will start with a low dose in the first group of patients. The dose of radiation will then proceed to successively higher doses of radiation for patient groups two, three and four, if it has been shown safe to do so.

SIRT treatment uses SIR-Spheres microspheres, which are tiny beads about a third the width of a human hair that emit radiation that is designed to kill tumours. Millions of SIR-Spheres are injected by a specially trained doctor known as an Interventional Radiologist into the blood vessel(s) that supply blood to the tumours. After being injected into the blood vessels that supply the tumours, the SIR-Spheres lodge in the tiny blood vessels of the tumour, where they emit their radiation directly into the tumour, with the aim of destroying the tumour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31523 0
Prof Paul de Souza
Address 31523 0
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country 31523 0
Australia
Phone 31523 0
+61 2 9598 5555
Fax 31523 0
Email 31523 0
P.Desouza@unsw.edu.au
Contact person for public queries
Name 14770 0
Dr Katerina Ajami
Address 14770 0
Level 33, 101 Miller Street, North Sydney, NSW, 2060
Country 14770 0
Australia
Phone 14770 0
+61 2 9964 8400
Fax 14770 0
Email 14770 0
kajami@sirtex.com
Contact person for scientific queries
Name 5698 0
Dr David Cade
Address 5698 0
Level 33, 101 Miller Street, North Sydney, NSW, 2060
Country 5698 0
Australia
Phone 5698 0
+61 2 9964 8400
Fax 5698 0
Email 5698 0
dcade@sirtex.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary