A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
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ClinicalTrials.gov Identifier: NCT01676428 |
Recruitment Status
:
Completed
First Posted
: August 31, 2012
Last Update Posted
: November 1, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Radiation: Radiotherapy | Not Applicable |
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total duration of accrual is approximately 24 months, with all patients expected to complete all protocol treatment and imaging within a further 3 months. The trial will close after the last patient has completed his/her last protocol related follow-up visit (at 12 months post-treatment).
Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of the dose (D99=100%). It is anticipated that most treatments should be highly conformal. Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed within 3 weeks or concurrently with respect to the investigational treatment. Consultation with the treating radiation oncologist is strongly recommended if chemotherapy is to be considered after the investigational treatment and before documented disease progression, to prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from this recommendation.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | November 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Radiotherapy
The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size. For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
Radiation: Radiotherapy
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size. For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
- The number of patients who complete prescribed treatment. [ Time Frame: After 24 months ]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)
- Toxicity of SBRT in study patients measured using CTCAE V4.0 [ Time Frame: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months ]
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 asn defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE V4.0.
- Efficacy of stereotactic radiosurgery [ Time Frame: 1 year after treatment ]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 a CT evaluation of change in tumour size.
- Feasibility of using Diffusion weighted-MRI for response assessment. [ Time Frame: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days) ]Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years old
-
All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
- 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
- Cohort 2: single adrenal metastases with extra‐adrenal disease controlled
- ECOG performance of 0‐2 inclusive.
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Informed consent.
Exclusion Criteria:
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
- Previous high‐dose radiotherapy to upper abdomen

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): NCT01676428
Australia, Victoria | |
Peter MacCallum Cancer Centre | |
East Melbourne, Victoria, Australia, 3002 |
Principal Investigator: | Shankar Siva | Peter MacCallum Cancer Centre, Australia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Peter MacCallum Cancer Centre, Australia |
ClinicalTrials.gov Identifier: | NCT01676428 History of Changes |
Other Study ID Numbers: |
11/106 U1111-1132-5574 ( Registry Identifier: ANZCTR ) |
First Posted: | August 31, 2012 Key Record Dates |
Last Update Posted: | November 1, 2016 |
Last Verified: | March 2016 |
Keywords provided by Peter MacCallum Cancer Centre, Australia:
Kidney Renal Radiotherapy Stereotactic Cancer |
Additional relevant MeSH terms:
Kidney Neoplasms Carcinoma, Renal Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Kidney Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |