Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney (FASTRACK II)

Trans Tasman Radiation Oncology Group

Status and phase: Active, not recruiting; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Radiation: SABR

Study type: Interventional

Funder types: Other

Identifiers

NCT02613819

TROG 15.03

Details and patient eligibility

About

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

Full description

Who is it for?

• Age > 18 years old
• All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
• ECOGperformance of 0-2 inclusive.
• Life expectancy > 9 months
• Either medically inoperable, technically high risk for surgery or decline surgery.
• Multidisciplinary decision for active treatment

Study Details:

Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.

Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).

All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Stereotactic Ablative Body Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: SABR