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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of patients who complete prescribed treatment.

Outcome Description:

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)

Outcome Time Frame:

After 24 months

Safety Issue:

No

Principal Investigator

Shankar Siva

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Human Research Ethics Committee

Study ID:

11/106

NCT ID:

NCT01676428

Start Date:

May 2012

Completion Date:

April 2015

Related Keywords:

  • Cancer
  • Kidney
  • Renal
  • Radiotherapy
  • Stereotactic
  • Cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis

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