A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
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Purpose
This is a "proof of concept" study, to assess the feasibility of introducing a novel high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia. This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated adrenal metastases from non-small cell carcinoma who are either medically inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients with renal cell carcinoma, both patients with primary disease only, and those patients who have limited metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment, this study will be to assess efficacy, toxicity and tumour response using a novel imaging biomarker called diffusion weighted-MRI.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Radiation: Radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases |
- The number of patients who complete prescribed treatment. [ Time Frame: After 24 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01676428
| Contact: Shankar Siva | +61 3 96561111 | siva.shankar@petermac.org |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Contact: Shankar Siva +61 3 96561111 | |
| Principal Investigator: Shankar Siva | |
| Principal Investigator: | Shankar Siva | Peter MacCallum Cancer Centre, Australia |
More Information
No publications provided by Peter MacCallum Cancer Centre, Australia
Additional 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 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 28, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Peter MacCallum Cancer Centre, Australia:
|
Kidney Renal Radiotherapy Stereotactic Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Kidney Diseases Kidney Neoplasms Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms Urologic Diseases Urologic Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015