Radiochirurgie stéréotaxique ablative focale des cancers du rein (FASTRACK II)
Radiochirurgie focale ablative STéréotactique pour les cancers du rein, un essai clinique de phase II (FASTRACK II)
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Victoria
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East Melbourne, Victoria, Australie, 3000
- Peter MacCallum Cancer Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Stereotactic Ablative Body Radiotherapy
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 |
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
Délai: 12mths post treatment
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Responsive Evaluation Criteria in Solid Tumors (RECIST) |
12mths post treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Estimation du taux d'échec à distance après SABR évalué par tomodensitométrie et évaluation clinique
Délai: De la date de randomisation jusqu'à la date de la première progression documentée ou la date du décès quelle qu'en soit la cause, selon la première éventualité, évaluée à 6 mois, 9 mois, 12 mois, 18 mois, 33 mois, 42 mois, 51 mois et 60 mois après le traitement
|
De la date de randomisation jusqu'à la date de la première progression documentée ou la date du décès quelle qu'en soit la cause, selon la première éventualité, évaluée à 6 mois, 9 mois, 12 mois, 18 mois, 33 mois, 42 mois, 51 mois et 60 mois après le traitement
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Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
Délai: 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
|
Common Terminology Criteria for Adverse Events (CTCAE) |
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
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Estimated Survival after SABR assessed by clinincal assessment
Délai: assessed up to 60 months
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Stereotactic Ablative Radiotherapy (SABR) |
assessed up to 60 months
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Renal Function Change after SABR assessed by split renal function and GFR
Délai: Baseline, 12mths post treatment, and 24 mths post treatment
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Calculated Glomular Filtration Rate (GFR) |
Baseline, 12mths post treatment, and 24 mths post treatment
|
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Renal Function Change after SABR assessed by using eGFR
Délai: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
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Estimated Glomular Filtration Rate (eGFR) |
Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shankar Siva, A/Prof, Peter MacCallum Cancer Centre, Australia
Publications et liens utiles
Publications générales
- 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.
- Siva S, Ali M, Hardcastle N, Kron T, Higgs B, Foroudi F, Ruben J, Appu S, Martin J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Chander S, Sidhom M, Vanneste BGL, Murphy DG, Lawrentschuk N, Pryor D, Wood S, Moon D, Bressel M. Ultra-hypofractionated stereotactic ablative body radiotherapy for primary renal cell carcinoma: 5-year outcomes from a pooled analysis of the FASTRACK trials. Lancet Oncol. 2026 Jun;27(6):721-728. doi: 10.1016/S1470-2045(26)00170-1. Epub 2026 May 17.
- Siva S, Pryor D, Martin J, Hardcastle N, Moon D, Kron T, Higgs B, Foroudi F, Ruben J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Lawrentschuk N, Appu S, Vanneste BGL, Hofman MS, Murphy DG, De Abreu Lourenco R, Mancuso P, Brook NR, Raman A, Wong LM, Sidhom M, Wood S, Ali M, Bressel M. Long-term outcomes of stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a multicentre, non-randomised, phase 2 study. Lancet Oncol. 2026 Jun;27(6):711-720. doi: 10.1016/S1470-2045(26)00091-4. Epub 2026 May 17.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs urologiques
- Carcinome
- Tumeurs rénales
- Carcinome à cellules rénales
Autres numéros d'identification d'étude
- TROG 15.03
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