CORE : A Randomised Trial of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Radiotherapy<br/>TrialTypeRadiotherapy
Trial

Two/ThreePhase Two/Three

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Radiotherapy | Breast,Lung,Urinary systemBreast,Lung,Non-Small Cell Lung Cancer,Prostate

Trial Overview Read MoreRead more

This phase II/III trial is comparing standard of care techniques for patients with Prostate, Breast or Non-Small Cell (NSC) Lung cancer, with a type of stereotactic body radiotherapy .
 

This trial is treating patients with Breast cancer, Prostate cancer or Non-Small Cell (NSC) Lung cancer.

This is a radiotherapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Randomised Trial of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases

Other Non-Commercial Sponsor

Institute of Cancer Research (ICR)

Summary

CORE is a phase II/III, multi-centre, non-blinded, parallel group randomised controlled trial in patients with breast, prostate or NSCLC primary cancer comparing standard of care (SOC) with or without SBRT for extra-cranial metastases. The aim of the phase II study is to demonstrate 1) feasibility of recruitment, 2) deliverability of the study in a multi-centre setting and 3) activity of SBRT, based on progression free survival, across the three tumour types. If all three aims are achieved the trial will be amended to roll into parallel tumour-site specific phase III trials. Eligible patients are those with either primary breast, prostate or NSCLC who have presented with ≤3 extra-cranial, metachronous, oligometastases, all suitable for SBRT. Patients will be randomised in a 1:1 ratio to either SOC or SOC with the addition of SBRT. Choice of SOC treatment is at the discretion of the local oncologist and defined per patient prior to randomisation (see section 8). Patients randomised to SBRT+SOC will receive a dose and fractionation regimen dependent on the metastatic site and proximity to dose limiting organs and normal tissues. Treatment will take place within 6 weeks of randomisation. The average scheme would be 3 treatments over 5 days but the maximum period of SBRT duration could be 8 treatments over 19 days. All patients will be reviewed every 3 months with a clinical examination and tumour markers (where applicable) during years 1 and 2, and 6 monthly thereafter to 5 years. Staging and follow up imaging protocols will be tumour type dependent: Breast: 3 monthly CT scans for years 1 and 2, and 6 monthly thereafter to 5 years. NSCLC: 3 monthly CT scans for years 1 and 2, 6 monthly to year 3, then annually to 5 years. Prostate: CT scans will be performed at 6, 12 and 24 months with imaging triggered by appropriate PSA rises. A rising PSA defined as 2 successive PSA rises from nadir, measured a minimum of 4 weeks apart. If the overall PSA rise has a doubling time of ≥ 3 months or the PSA level has doubled the original PSA value at trial entry or if clinically indicated, then restaging should be considered. All patients will have a toxicity assessment at each clinic visit and patient reported quality of life (QOL) assessment at 3, 6, 12, 18 and 24 months.

Recruiting Hospitals Read MoreRead more

Peter MacCallum Cancer Centre, Radiation Oncology
Parkville
Mr Daniel Hamilton
Daniel.hamilton@petermac.org
03 8559 8488

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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