At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Stereotactic body radiotherapy (radiation), Palliative RT (radiation)
- How long the study runs
- Study runs about 104 months (dates as stated)
- About the drug or intervention
- Stereotactic body radiotherapy — radiation: Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. · Palliative RT — radiation: Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by the European Organisation for Research and Treatment of Cancer (EORTC), is looking at stereotactic body radiotherapy — a very precise, focused form of radiotherapy — for people with rare cancers that have spread to a small number of places in the body (between 1 and 5 tumours, known as oligometastasis). It covers a range of rarer cancer types, such as gynaecological, skin, head and neck, kidney, bladder, pancreatic, stomach and bowel (other than colorectal) cancers. The trial aims to treat all the places the cancer has spread to.
Who can take part
- Adults aged 18 or over
- A confirmed cancer that has spread, shown on scans (a biopsy of the spread is preferred but not essential)
- The original tumour has been treated and is under control, with no growth at the original site for at least 3 months
- Between 1 and 5 areas of spread in total, including brain secondaries that can be treated with targeted radiotherapy or were removed by surgery
- All areas of disease can be safely treated with radiotherapy, in the view of an experienced radiotherapy doctor
- Able to carry out daily activities at least half the time (performance score 0–2)
- Expected to live more than 6 months
- Written informed consent given before joining the trial
Who may not be able to
- Primary cancer of the prostate, breast, lung or colorectal area
- Serious other health conditions that make radiotherapy unsafe, such as interstitial lung disease, Crohn's disease, ulcerative colitis, lupus or scleroderma in the area to be treated
- Moderate or severe liver problems (Child Pugh B or C) if the cancer has spread to the liver
- A lot of overlap with an area previously treated with radiotherapy
- Cancer that has spread only to the brain
- Fluid build-up caused by cancer (around the lungs or in the tummy), or cancer spread in the lining of the brain or tummy
- Tumours outside the brain larger than 6 cm (bone secondaries over 5 cm may be allowed if the doctor believes they can be treated safely)
- Evidence of spinal cord compression causing symptoms, unless surgery has already been done
- Cancer that has grown into the digestive tract (gullet, stomach or bowel), certain lymph nodes, the skin in a widespread way, or lymph vessels
- Women who are pregnant or breastfeeding
- Any personal, family, social or travel situation that might make it hard to follow the trial plan and attend follow-up visits
What taking part involves
- • Targeted stereotactic body radiotherapy (a precise, focused type of radiotherapy) aimed at all areas where the cancer has spread
Time commitment: Not stated — ask the trial team about how many hospital visits, how long treatment takes, and what follow-up is involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2021-06-10
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for gynecologic cancer
- • NA - 200 participants
- • This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gynecologic cancer
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
- • London - Royal Marsden Hospital - site: Chelsea, London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓confirmed by a biopsy cancer with that has spread disease detected on imaging. Biopsy of metastasis is preferred,...
- ✓Controlled primary tumour, defined as:
- ✓at least 3 months since original tumour treated definitively, with no progression at primary site
- ✓Total number of oligometastases of 1-5 including:
- ✓All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist
Who cannot take part
- ✗Primary cancer of prostate, breast, lung or colorectal
- ✗Serious medical other health conditions precluding radiotherapy:
- ✗For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
- ✗Brain metastases only, without extra-cerebral metastases
- ✗Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
See the full criteria
Where Is This Study? (2 UK sites)
University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
Birmingham B15 2TH, United Kingdom
Royal Marsden Hospital - site: Chelsea, London
London SW3 6JJ, United Kingdom
How to Get in Touch
EORTC HQ
Sponsor contactCONTACT
