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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier:
NCT01676428
First received: August 14, 2012
Last updated: May 6, 2015
Last verified: April 2015
  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

Resource links provided by NLM:


Further study details as provided by Peter MacCallum Cancer Centre, Australia:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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: November 2015
Estimated Primary Completion Date: November 2015 (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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:

    1. 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
    2. 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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676428

Locations
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
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: May 6, 2015
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 July 30, 2015