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Closed (no longer recruiting)Last updated: 12 February 2024

FASTRACK II: This phase II trial is trying to determine the effectiveness of using focal ablative stereotactic radiosurgery (targeted radiotherapy) for the treatment of primary kidney cancerA Mulicentre Phase II clinical trial of STereotactic Ablative Body Radiotherapy for Primary Kidney Cancer

Clinical summary

Summary

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. 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).

Conditions

This trial is treating patients with primary kidney cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

FASTRACK II

More information

Trial Identifiers

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Trial sponsor

Trans Tasman Radiation Oncology Group (TROG)

Scientific Title

A Mulicentre Phase II clinical trial of STereotactic Ablative Body Radiotherapy for Primary Kidney Cancer

Eligibility

Inclusion

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

Exclusion

1. 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.
2. Previous high-dose radiotherapy to an overlapping region
3. Tumours of larger than 8cm is size

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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