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

NCT01676428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-11-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Shankar Siva · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-10-31
Completion
2015-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676428 on ClinicalTrials.gov