Breast Cancer Clinical Trial
— COREOfficial title:
A Randomised Trial of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases
Verified date | August 2019 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 245 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria 1. Age = 18 years 2. WHO performance status 0-2 3. Histological confirmation of primary malignancy (histological confirmation of metastasis is not mandatory but should be performed in any situation where there is diagnostic uncertainty). Patients with breast, NSCLC or prostate primary malignancies are eligible. 4. Predicted life expectancy > 6 months 5. = 3 metastatic lesions (total). A maximum of 2 different organ systems (e.g. liver, lung, bone, nodal) may contain metastases but the total number of lesions must not exceed 3. For example, a patient with 3 liver metastases or 1 liver metastasis and 2 lung metastases would be eligible. A patient with 1 lung metastasis, 1 liver metastasis and an adrenal metastasis is ineligible. 6. All metastases must be visible, imaging defined targets and be suitable for treatment with SBRT in accordance with the dose fractionation options specified in the protocol. (See the associated CORE trial radiotherapy delivery guidelines for detailed SBRT guidance by metastatic site) 7. Patients who have received prior ablative therapy (e.g. surgery, RFA or SBRT) for metastatic disease are eligible, as long as this site is controlled on imaging at the point of trial entry and the total number of metastases over time since diagnosis of metastatic disease does not exceed 3. Patients with 2 or 3 metastases in which ablative therapy (e.g. surgery/RFA) to 1 site is deemed appropriate as part of standard therapy may be entered into the trial following successful delivery of the ablative treatment. Ablative therapy (e.g. surgery, RFA, cryoablation, SBRT) is not permissible as a standard of care option following randomisation for patients as part of the trial. 8. Only patients with metachronous metastatic disease presentation are eligible. Primary site must be controlled. NSCLC patients with synchronous presentation of a single brain metastasis with the primary lung malignancy are eligible as long as both sites of disease have received radical treatment. Both primary lung site and solitary synchronous brain metastasis must be controlled at trial entry, and the total number of metastases over time including the brain metastasis must not exceed 3. Permissible disease-free intervals are: Breast: = 6 months from completion of radical treatment including any adjuvant therapy to diagnosis of metastases. Patients who have relapsed whilst on adjuvant endocrine therapy are eligible. NSCLC: = 4 months from completion of radical treatment (not including any adjuvant chemotherapy) to diagnosis of metastases. Prostate: = 6 months from completion of radical treatment including any adjuvant therapy to diagnosis of metastases. Patients who have relapsed whilst on adjuvant endocrine therapy are eligible. 9. Only patients who are systemic therapy naïve in the metastatic setting are eligible. Prior systemic therapy in the adjuvant setting is permitted. Patients who have had a change in endocrine therapy due to the diagnosis of oligometastatic disease can be entered into the CORE trial as long as entry is within 8 weeks of this change in therapy for prostate cancer patients and within 10 weeks of this change in therapy for breast cancer patients. 10. Adequate baseline organ function to allow SBRT to all relevant targets dependent on location of metastatic subsite 11. Negative pregnancy test (for women of childbearing potential) 12. Written informed consent. Exclusion criteria 1. Intra-cranial metastases (not meeting above inclusion criterion 8). 2. Malignant pleural effusion 3. Malignant peritoneal disease 4. Any single metastasis >6cm,( >5cm for lung metastases) 5. Prior radiotherapy to a site that precludes safe delivery of SBRT 6. Co-morbidities precluding staging or follow up imaging, or precluding procedures required to facilitate SBRT 7. Loco-regional nodal relapse where surgery is considered the standard of care and is technically feasible. Patients with internal mammary chain or supraclavicular fossa lymph node relapses of breast cancer are eligible if SBRT dose constraints can be met. Patients with axillary nodal relapse from breast cancer are excluded 8. Spinal cord compression, or impingement of the cord or any other situation whereby the clinician feels that urgent radiotherapy to the spine is required (within 24 hours) 9. Any condition or significant clinical co-morbidities that preclude the safe delivery of SBRT (e.g. history of clinically significant diffuse interstitial lung disease if SBRT to lung metastases or lesions adjacent to lungs are considered or clinically significant colitis i.e. ulcerative colitis /Crohn's disease if SBRT to the pelvis or abdomen is considered). 10. Prostate cancer patients who have relapsed on Androgen Deprivation Therapy (ADT) which was started for biochemical relapse without staging investigations to define their relapse status, or who have relapsed on CAB which was started for biochemical relapse. 11. Prostate cancer patients receiving or have previously received abiraterone, enzalutamide or chemotherapy e.g. docetaxel. 12. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival. 13. Patients whose entry to the trial will cause unacceptable clinical delays to their planned management. 14. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. |
Country | Name | City | State |
---|---|---|---|
Australia | GenesisCare - Adelaide Radiotherapy Centre | Adelaide | South Australia |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | Austin Health | Melbourne | Victoria |
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Calvary Mater Newcastle | Waratah | New South Wales |
United Kingdom | Belfast City Hospital | Belfast | |
United Kingdom | Queen Elizabeth Hospital | Birmingham | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | The Beatson | Glasgow | |
United Kingdom | Royal Surrey County Hospital | Guildford | |
United Kingdom | St James's University Hospital | Leeds | |
United Kingdom | Leicester Royal Infirmary | Leicester | |
United Kingdom | Guy's Hospital | London | |
United Kingdom | Mount Vernon Cancer Centre | London | Surrey |
United Kingdom | Royal Marsden Hospital | London | |
United Kingdom | St Bartholomew's Hospital | London | |
United Kingdom | University College Hospital | London | |
United Kingdom | The Christie Hospital | Manchester | |
United Kingdom | James Cook University Hospital | Middlesborough | |
United Kingdom | Freeman Hospital | Newcastle upon Tyne | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United Kingdom | Churchill Hospital | Oxford | Oxfordshire |
United Kingdom | Weston Park Hospital | Sheffield | |
United Kingdom | Royal Marsden Hospital | Sutton | |
United Kingdom | Clatterbridge Cancer Centre | Wirral |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust | Institute of Cancer Research, United Kingdom, National Health Service, United Kingdom |
Australia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Freedom from widespread metastatic disease (FFWMD) | FFWMD will be measured from the time of randomisation until radiological evidence of disease progression, which is not suitable for radical salvage therapy. | Pre-treatment and at 3,6,9,12,15,18,21,24,30,36,42,48,54 and 60 months post treatment | |
Primary | Progression Free Survival | Time from randomisation to evidence of progression of cancer at any site or death from any cause | 60 months post treatment | |
Secondary | Feasibility of recruitment | Recruitment rate and proportion of patients receiving SBRT (if allocated) in the absence of new developing widespread disease | 3 years from first patient | |
Secondary | Feasibility of SBRT delivery | Recruitment of patients receiving SBRT within the dosimetric constraints | 3 years from first patient | |
Secondary | Overall Survival | Time from randomisation until time of death from any cause | 60 months post treatment | |
Secondary | Local lesion control | Time from randomisation until radiological evidence of progression at the treated site and be measured on a lesion based on analysis using RECIST criteria. | 60 months post treatment | |
Secondary | Clinical reported acute and late toxicity | Clinician reported acute and late toxicity will be graded using NCI CTCAE v4.0 / RTOG systems. Acute events are defined as those occurring up to 3 months follow-up; late events are reported from 6 months post randomisation. | 60 months post treatment | |
Secondary | Patient reported Quality of Life | Patient reported quality of life will be measured using EORTC QLQ C30 | Pre-treatment and at 3,6,12,18 and 24 months post treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |