ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000759897

Ethics application status

Approved

Date submitted

17/07/2012

Date registered

17/07/2012

Date last updated

18/07/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

A pilot study of Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.

Scientific title

A pilot study of the feasibility of performing Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1132-5574

Trial acronym

FASTRACK

Linked study record

Health condition

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

Primary Renal Cell Carcinoma

Metastatic non-small cell carcinoma to the adrenal gland

Condition category

Condition code

Cancer

Kidney

Cancer

Other cancer types

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

For lesions less than 5cm - Image guided single fraction radiosurgery to26Gy prescribed to covering isodose. This is a single session of radiotherapy taking approximately 1 hour.
For lesions greater than or equal to 5cm - Image guided fractionated Stereotactic Body Radiotherapy (SBRT) to 45Gy in 3 fractions prescribed to covering isodose. This is 3 sessions of radiotherapy, delivered at least 48 hours apart, taking approximately 1 hour per session.
Prior to radiotherapy commencing, both treatment groups require a planning visit which will last approximately 1 hour, as well as a further 'mock-up' visit which will last approximately 45 minutes.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The number of patients who complete prescribed treatment. This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s).

Timepoint [1]

Following treatment

Secondary outcome [1]

Toxicity of SBRT in study patients measured using CTCAE V4.0
Specific toxicities will include, but are not limited to:
-Gastrointestinal (nausea, vomiting, diarrhoea, acute ulceration)
-Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis).
-Skin/chest wall (radiation dermatitis, rib fracture)
-Kidney (acute renal dysfunction)
Freedom from severe toxicity will be reported and defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE v 4.0

Timepoint [1]

Between 2-4 weeks after radiotherapy and 3 monthly for 12 months

Secondary outcome [2]

Efficacy of stereotactic radiosurgery
Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are an CT evaluation of change in tumour size.

Timepoint [2]

1 year after treatment

Secondary outcome [3]

Feasibility of using Diffusion weighted-MRI for Response Assessment: Feasibility will be measured by the quality of image of the Diffusion weighted-MRI scan recorded by the investigating radiologists.

Timepoint [3]

At Baseline, 14 days (+/-3 days) and at the definitive respose assessment (70 days (+/- 10 days)

Eligibility

Key inclusion criteria

-Age > 18 years old
-All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
(a) Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or
(b) Cohort 2: solitary adrenal metastases with with primary disease controlled
-ECOG performance of 0-2 inclusive.
-Either medically inoperable, technically high risk for surgery or decline surgery.
-Informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Targeted agents (such as sunitinib) are allowable.
-Any patient who is currently pregnant or breastfeeding.
-Previous high-dose radiotherapy to upper abdomen

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)

To register a patient onto the trial, an adequately qualified and authorized member of the research team at the trial site must complete the registration and eligibility Case Report Forms (CRFs) and forward them to the trials coordinator at the Peter MacCallum Centre Department of Radiation Oncology.
Prior to patient enrolment, the investigator should ensure that all of the following requirements are met:
*The patient meets all inclusion criteria and none of the exclusion criteria should apply.
*The patient has signed and dated the consent form
*All pre-treatment investigations and assessments have been performed.
*The eligibility checklist has been completed, signed and dated.
The Trial Coordinator will verify the completeness of the eligibility checklist upon receipt of the document and follow up with the participating investigator in the event of a discrepancy.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Non-randomised

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

FASTRACK is a 2 -cohort, non-randomised prospective feasibility study.

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/05/2012

Actual

21/05/2012

Date of last participant enrolment

Anticipated

Actual

25/08/2014

Date of last data collection

Anticipated

Actual

12/10/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

CASS Foundation

Address [1]

Level 2, 111 Collins Street
Melbourne
Victoria 3000

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Shankar Siva

Address

Peter MacCallum Cancer Centre
Locked Bag 1 A'Beckett St
Vic 8006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Ethics Committee

Ethics committee address [1]

Peter MacCallum Cancer Centre, 1 A'Beckett St, Melbourne, Victoria, 8006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/04/2012

Ethics approval number [1]

11_106

Summary

Brief summary

Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be effective in controlling cancer in other sites in the body, including the lung and the liver. We aim to test the ability of this new technique to control cancers in the kidney. This is the first step of the research, and is a ‘pilot’ study. 
Who is it for? You may be eligible to join this study if you are aged greater than 18 years and have a radiological diagnosis or biopsy confirmed diagnosis of either renal cell carcinoma or solitary adrenal metastases. Trial Details If you participate in this study, you will have either a single session of stereotactic body radiotherapy (SBRT) or three sessions of SBRT, depending on how big your cancer is. In order to deliver this treatment, you will need to attend a ‘planning’ session where your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be physically delivered when it comes to the time of treatment. This session will take approximately 45 minutes. When the treatment starts, the total time required to deliver the treatment will be one hour. In addition to the visits required to plan and deliver the radiotherapy, blood samples will be taken as part of this research. These will be taken at the same time as blood is collected to assess your kidney function (which would be standard care). Therefore will not require any additional blood collection visits than would be routinely performed to treat your cancer. Both the kidney function blood sample (standard of care) and the research related blood sample will be taken a total of 3 times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. If you have a primary kidney cancer (renal cell carcinoma), then in addition to the steps outlined above you will have a research related ‘Diffusion weighted-MRI’ scan performed a total of three times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. The Diffusion weighted-MRI scan is similar to a standard MRI scan, but is taken over a longer period of time. Each Diffusion weighted-MRI scan takes approximately 30 minutes. For those patients with adequate kidney function, you will also have a contrast injection at the time of the MRI, which will add an additional 10 minutes to the scan time. The MRI allows us to examine the blood flow into kidneys and the cancer. 
To assess the function of the kidney after the SBRT treatment, a ‘positron emission tomography’ (PET) scan will be taken at approximately the same timepoints as the perfusion scans; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. This will involve injection of a radioactive tracer and a subsequent scan which will take approximately 30 minutes to capture.  This will require you attending the PET Centre for a period of 2 or 3 hours. Participation in this study will involve no extra cost due to either having these scans or the treatment.

Trial website

Trial related presentations / publications

Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1061-8. doi: 10.1016/j.ijrobp.2014.07.043. Epub 2014 Oct 13.
  https://www.ncbi.nlm.nih.gov/pubmed/?term=Stereotactic+Ablative+Body+Radiation+Therapy+for+Primary+Kidney+Cancer%3A+A+3-Dimensional+Conformal+Technique+Associated+With+Low+Rates+of+Early+Toxicity


https://insights.ovid.com/asia-pacific-clinical-oncology/apjco/2015/07/002/tolerability-stereotactic-ablative-body/29/01253234


Stereotactic ablative body radiotherapy for inoperable primary kidney cancer: a prospective clinical trial
https://onlinelibrary.wiley.com/doi/abs/10.1111/bju.13811




http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e16587
________________________________________
Assessing DCE-MRI and DWI as treatment response biomarkers after SABR for primary renal cell carcinoma.
Hayley M Reynolds, Bimal Parameswaran, Diana Roettger, Mary Finnegan, Eddie Lau, Tomas Kron, Mark Shaw, Sarat Chander, and Shankar Siva
Journal of Clinical Oncology 2018 36:15_suppl, e16587-e16587

Public notes

Contacts

Principal investigator

Name

Dr Dr Shankar Siva

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006

Country

Australia

Phone

+61 3 85595000

Fax

+61 3 8559 7729

shankar.siva@petermac.org

Contact person for public queries

Name

Dr Shankar Siva

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006

Country

Australia

Phone

+61 3 85595000

Fax

+61 3 8559 7729

shankar.siva@petermac.org

Contact person for scientific queries

Name

Dr Shankar Siva

Address

Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006

Country

Australia

Phone

+61 3 85595000

Fax

+61 3 8559 7729

shankar.siva@petermac.org

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

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