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Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

NCT ID: NCT04498767

View on ClinicalTrials.gov ↗

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.

Gynecologic CancerSkin CancerHead and Neck CancerSarcomaRenal CancerBladder CancerUpper Urinary Tract CarcinomaPancreatic CancerHepatobiliary CancerGastric CancerSmall Bowel CancerEsophageal CancerMelanomaColon CancerOligometastasis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * 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: * Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases * All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist * ECOG score 0-2 * Life expectancy \> 6 months * Age 18 or older * Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Primary cancer of prostate, breast, lung or colorectal * Serious medical comorbidities precluding radiotherapy: * These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma. * For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C) * Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators * Brain metastases only, without extra-cerebral metastases * Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis * Maximum size of 6 cm for lesions outside the brain, except: * Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis) * Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases. * Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis * Pregnant or breast feeding women * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Where Is This Study? (2 UK sites)

University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Royal Marsden Hospital - site: Chelsea, London

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

EORTC HQ

Sponsor contact

CONTACT

+32 2 7744 1611 eortc@eortc.org
Data sourced from ClinicalTrials.gov · Last verified: 2024-08