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Completed

NCT Number: NCT01676428

A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Acronym: FASTRACK

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 31, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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