Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

NCT02613819 | Unknown Phase 2 DMC

• 1 other identifier: TROG 15.03
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria

  Responsive Evaluation Criteria in Solid Tumors (RECIST)

  12mths post treatment

Secondary Outcomes (5)

• Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4

  From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment

• Estimated Survival after SABR assessed by clinincal assessment

  assessed up to 60 months

• Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment

• Renal Function Change after SABR assessed by split renal function and GFR

  Baseline, 12mths post treatment, and 24 mths post treatment

• Renal Function Change after SABR assessed by using eGFR

  Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths

Study Arms (1)

Stereotactic Ablative Body Radiotherapy

EXPERIMENTAL

Stereotactic Ablative Body Radiotherapy (SABR) Treatment schedule 1: 26 Gray (Gy) in 1 fraction, for tumours of less than or equal to 4cm in size. Treatment schedule 2: 42 Gray (Gy) in 3 fractions, for tumours of greater than 4cm in size

Radiation: SABR

Interventions

SABR RADIATION

Renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy.

Also known as: Stereotactic Ablative Body Radiotherapy

Stereotactic Ablative Body 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 a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
• Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
• Life expectancy \> 9 months
• Either medically inoperable, technically high risk for surgery or decline surgery.
• Multidisciplinary decision for active treatment

You may not qualify if:

• Pre-treatment estimated glomerular filtration rate \< 30 mls/min
• 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 an overlapping region
• Tumours of larger than 8cm is size

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead

Study Sites (1)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3000, Australia

Location

Related Publications (2)

• Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.

  PMID: 38423047 DERIVED

• Siva S, Chesson B, Bressel M, Pryor D, Higgs B, Reynolds HM, Hardcastle N, Montgomery R, Vanneste B, Khoo V, Ruben J, Lau E, Hofman MS, De Abreu Lourenco R, Sridharan S, Brook NR, Martin J, Lawrentschuk N, Kron T, Foroudi F. TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II. BMC Cancer. 2018 Oct 23;18(1):1030. doi: 10.1186/s12885-018-4916-2.

  PMID: 30352550 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Shankar Siva, A/Prof

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiotherapy; * Fraction schedule 1: 26Gy in 1 fraction, for tumours \< 4cm in size * Fraction schedule 2: 42Gy in 3 fractions, for tumours \> 4cm in size

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 25, 2015
• Study Start: July 1, 2016
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

AU (1)