CORE Trial

Not Applicable

Completed

• Conditions: Extracranial oligometastases; Cancer

• Registration Number: ISRCTN45961438
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-02
• Study Completion: 2019-10-01
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 245

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 after ablative treatment, following successful delivery of clinical treatment.
8. Metachronous metastatic disease presentation only. Primary site must be controlled. Disease-free interval from completion of radical treatment (including any adjuvant therapy) to diagnosis of metastases:
8.1. Breast: = 6 months. Patients who have relapsed whilst on adjuvant endocrine therapy are eligible.
8.2. NSCLC: = 4 months
8.3. Prostate: = 6 months. Patients who have relapsed whilst on adjuvant endocrine therapy are eligible
9. Systemic therapy naïve in the metastatic setting
10. Adequate baseline organ function to allow SBRT to all relevant targets dependent on location of metastatic subsite for necessary baseline investigations)
11. Negative pregnancy test (for women of childbearing potential)
12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
13. Written informed consent

Exclusion Criteria

1. Intra-cranial metastases
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 or regional field radiotherapy is standard of care. Patients with supraclavicular, axillary and internalmammary nodal relapse from breast cancer are excluded
8. Spinal cord compression
9. Any condition or significant clinical co-morbidities that precludes the safe delivery of SBRT (eg history of clinically significant diffuse interstitial lung disease if SBRT to lung metastases or lesions adjacent to lungs are considered or clinically significant colitis ie ulcerative colitis /Crohn’s disease if SBRT to the pelvis or abdomen is considered)
10. Prostate cancer patients previously relapsing on Androgen Deprivation Therapy (ADT) or CAB and receiving abiraterone, enzalutamide or docetaxel are ineligible
11. Patients whose entry to the trial will cause unacceptable clinical delays to their planned management

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival is measured using RECIST at baseline, 3, 6, 9, 12, 15, 18, 21,24, 30, 36, 42, 48, 54 and 60 months post randomisation.