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

STATUS

Recruiting
End date

Jan 28, 2029
participants needed

204
sponsor

David Palma

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Updated on 28 October 2022

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cancer

metastasis

primary tumor

stereotactic body radiation therapy

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.

Details

Condition	Metastatic Tumors
Treatment	Observation, Chemotherapy, Stereotactic Ablative Radiotherapy, Immunotherapy, Palliative Radiation, Hormones, Hormones
Clinical Study Identifier	NCT03721341
Sponsor	David Palma
Last Modified on	28 October 2022

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Eligibility		Yes	No	Not Sure
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

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