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Clinical Trials in Switzerland / NCT03721341
Active, not recruiting Phase 3

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

NCT03721341 · tracked via the Priya Life Science Switzerland tracker
Sponsor
David Palma
Phase
Phase 3
Started
2019-02-22
Last updated
2026-09-30

Condition(s) studied

Metastatic Tumors

Investigational drug(s) / intervention(s)

Palliative RadiationChemotherapyImmunotherapyHormonesObservationStereotactic Ablative Radiotherapy

Palliative Radiation: Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Chemotherapy: Chemotherapy may be given as indicated.

Immunotherapy: Immunotherapy may be given as indicated.

Hormones: Hormones may be given as indicated.

Observation: Observation only is acceptable if this is the standard practice.

Stereotactic Ablative Radiotherapy: Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily).

Study summary

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 or older * Willing to provide informed consent * Karnofsky performance score greater than 60 * Life expectancy greater than 6 months * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site * Total number of metastases 4-10 * All sites of disease can be safely treated based on a pre-plan Exclusion Criteria: * 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, 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 with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs. * Malignant pleural effusion * Inability to treat all sites of disease * Any single metastasis greater than 5 cm in size. * Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc. * Metastasis in the brainstem * Clinical or radiologic evidence of spinal cord compression * Dominant brain metastasis requiring surgical decompression * Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin * Pregnant or lactating women

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Alfred Health Melbourne Victoria
BC Cancer Agency, Vancouver Island Centre Victoria British Columbia
Nova Scotia Health Authortiy Halifax Nova Scotia
Health Sciences North Greater Sudbury Ontario
Grand River Hospital Kitchener Ontario
London Regional Cancer Program of the Lawson Health Research Institute London Ontario
Trillium Health Partners-Credit Valley Hospital Mississauga Ontario
Niagra Health System St. Catharines Ontario
University Health Network Toronto Ontario
Centre hospitalier de l'Université de Montréal-CHUM Montreal Quebec
VU University Medical Centre Amsterdam Netherlands
University Hospital of Zürich Zurich Switzerland
Western General Hospital Edinburgh United Kingdom
Beatson West of Scotland Cancer Centre Glasgow United Kingdom

More David Palma trials in Switzerland

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03721341 on ClinicalTrials.gov ↗ ← All trials in Switzerland