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

NCT01676428 | Completed DMC

• 2 other identifiers: 11/106U1111-1132-5574
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Kidney; Renal; Radiotherapy; Stereotactic; Cancer

Outcome Measures

Primary Outcomes (1)

• The number of patients who complete prescribed treatment.

  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)

  After 24 months

Secondary Outcomes (3)

• Toxicity of SBRT in study patients measured using CTCAE V4.0

  Between 2-4 weeks after radiotherapy and 3 monthly for 12 months

• Efficacy of stereotactic radiosurgery

  1 year after treatment

• Feasibility of using Diffusion weighted-MRI for response assessment.

  At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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

Interventions

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.

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (1)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Related Publications (1)

• Pham D, Thompson A, Kron T, Foroudi F, Kolsky MS, Devereux T, Lim A, Siva S. Stereotactic ablative body radiation therapy for primary kidney cancer: a 3-dimensional conformal technique associated with low rates of early toxicity. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1061-8. doi: 10.1016/j.ijrobp.2014.07.043. Epub 2014 Oct 13.

  PMID: 25442039 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shankar Siva

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 31, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: November 1, 2016

Record last verified: 2016-03

Locations

AU (1)