Breast Cancer Clinical Trial
Official title:
A Randomised Trial of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases
Metastatic spread of cancer from its primary site to distant organs is the commonest cause of
death from cancer. The term oligometastases describes an intermediate metastatic state, in
which cancer exists as a limited number of metastases at first, before cells acquire the
ability to metastasise more widely. For the large majority of solid cancers, once metastatic
disease has been diagnosed the chances of cure are small. There are several situations where
this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for
oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment
is justified. SBRT is targeted radiotherapy which destroys cancer cells in the area of the
body it is aimed at however low dose radiation may be received by surrounding tissue.
It is difficult to quantify incidence of patients with multiple primary cancers developing at
intervals that are representative of oligometastatic stage IV disease, (defined for the
purposes of this trial as ≤ 3 metastatic sites). However an increase in the use of
surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis
of patients with asymptomatic oligometastatic relapse becoming a more common clinical
occurrence. The CORE study is a randomized controlled trial that will be conducted in
patients with cancer in one of three primary sites where oligometastatic disease relapse is a
common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The study
will evaluate the use of SBRT in this patient population.
Eligible patients who consent to participate in this clinical trial will be randomized to
receive standard care or standard care plus SBRT we hope to recruit approximately 206
patients to the study and the primary outcome measure is progression free survival.
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.
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