Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
SABR-COMET 10
Clinical summary
Summary
This is a randomised trial with experimental and active comparator arms. In the Experimental Arm, participants will receive Stereotactic Ablative Radiotherapy (SABR) plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist. SABR: total dose of radiation of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30Gy in 3 fractions (every 2 days), or 35 in 5 fractions (daily). In the Active Comparator Arm, participants will receive standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, at the discretion of the treating oncologist. 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.
Conditions
This trial is treating people with metastatic cancers
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have had certain treatments, surgical procedures or drugs.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
David Palma
Scientific Title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information