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

Metastatic Tumors Clinical Trial

— SABR-COMET 10  

Official title:

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03721341
• Other study ID #: SABR-COMET 10
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 22, 2019
• Est. completion date: January 2029

Study information

• Verified date: December 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Tumors
• Neoplasm Metastasis

Intervention

Radiation:
• 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.

Drug:
• Chemotherapy
Chemotherapy may be given as indicated.
• Immunotherapy
Immunotherapy may be given as indicated.
• Hormones
Hormones may be given as indicated.

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

Radiation:
• 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).

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
David Palma	Amsterdam University Medical Centre, VUmc Site, Beaston West of Scotland Cancer Centre, British Columbia Cancer - Centre for the North, London Health Sciences Centre

Countries where clinical trial is conducted

Australia,  Canada,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival at Study Completion	Time from randomization to death from any cause.	At approximately end of year 6 (study completion)
Secondary	Progression-free Survival	Time from randomization to disease progression at any site or death.	At approximately year 3, and end of year 6 (study completion)
Secondary	Time from randomization to development of new metastatic lesions	New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.	At approximately end of year 6 (study completion)
Secondary	Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire		At approximately end of year 6 (study completion)
Secondary	Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire		At approximately end of year 6 (study completion)
Secondary	Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0		End of years 1, 2, 3, 4, 5, and 6 (study completion)
Secondary	Overall Survival at midpoint of Study		At approximately year 3 (midpoint)