ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

RESIRT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Renal Cell Carcinoma

Condition category

Condition code

Cancer

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]

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]

Safety and toxicity will be assessed using the National Cancer Institute Common Terminology Criteria (NCICTC) version 4.0.

Timepoint [1]

30 post-SIRT

Secondary outcome [1]

Tumour Response (Response will be calculated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria).

Timepoint [1]

12 Months post-SIRT

Secondary outcome [2]

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]

12 Months post-SIRT

Secondary outcome [3]

Overall survival (OS) is defined as the time interval between the date of study entry and the date of
death.

Timepoint [3]

12 months post-SIRT

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/09/2010

Actual

6/09/2011

Date of last participant enrolment

Anticipated

Actual

13/04/2016

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]

Commercial sector/Industry

Name [1]

Sirtex Technology Pty Ltd

Address [1]

Level 33, 101 Miller Street, North Sydney, NSW, 2060

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/07/2010

Ethics approval number [1]

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

Prof Paul de Souza

Address

St George Private Hospital
1 South Street
Kogarah NSW 2217

Country

Australia

Phone

+61 2 9598 5555

Fax

P.Desouza@unsw.edu.au

Contact person for public queries

Name

Katerina Ajami

Address

Level 33, 101 Miller Street, North Sydney, NSW, 2060

Country

Australia

Phone

+61 2 9964 8400

Fax

kajami@sirtex.com

Contact person for scientific queries

Name

David Cade

Address

Level 33, 101 Miller Street, North Sydney, NSW, 2060

Country

Australia

Phone

+61 2 9964 8400

Fax

dcade@sirtex.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Post-radioembolization yttrium-90 PET/CT - part 1: diagnostic reporting	2013	https://doi.org/10.1186/2191-219x-3-56
Embase	RESIRT: A Phase 1 Study of Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres in Patients With Primary Renal Cell Carcinoma.	2022	https://dx.doi.org/10.1016/j.clgc.2022.05.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically