Using stereotactic body radiotherapy for patients with rare oligometastatic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of adding stereotactic body radiotherapy (SBRT) to standard care in improving overall survival for patients with rare oligometastatic cancers. Participants will be randomly assigned to receive either standard treatment alone or standard treatment plus SBRT targeting all known metastatic sites. The study aims to determine if this combination can lead to better outcomes compared to standard care alone. It involves multiple centers and focuses on a specific group of patients with limited metastatic disease.

Why it matters

Who can join: the full rules

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 it's running

• Institut Jules Bordet
  Anderlecht, Belgium Recruiting
• Universitair Ziekenhuis Gent
  Ghent, Belgium Recruiting
• Gasthuiszusters Antwerpen - Sint-Augustinus
  Wilrijk, Belgium Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Gustave Roussy
  Villejuif, France Recruiting
• Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
  Hamburg, Martinistrasse 52, Germany Recruiting

Study contacts

• Principal investigator: Matthias Guckenberger — University of Zurich
• Study coordinator: Eortc Hq
• Email: eortc@eortc.org
• Phone: +32 2 7744 1611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.