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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03721341




Registration number
NCT03721341
Ethics application status
Date submitted
23/10/2018
Date registered
26/10/2018

Titles & IDs
Public title
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
Scientific title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
Secondary ID [1] 0 0
SABR-COMET 10
Universal Trial Number (UTN)
Trial acronym
SABR-COMET 10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Palliative Radiation
Treatment: Drugs - Chemotherapy
Treatment: Drugs - Immunotherapy
Treatment: Drugs - Hormones
Other interventions - Observation
Treatment: Other - Stereotactic Ablative Radiotherapy

Active comparator: Standard arm - Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.

Experimental: Stereotactic Arm - Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.


Treatment: Other: 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.

Treatment: Drugs: Chemotherapy
Chemotherapy may be given as indicated.

Treatment: Drugs: Immunotherapy
Immunotherapy may be given as indicated.

Treatment: Drugs: Hormones
Hormones may be given as indicated.

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

Treatment: Other: 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).
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival at Study Completion
Timepoint [1] 0 0
At approximately end of year 6 (study completion)
Secondary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
At approximately year 3, and end of year 6 (study completion)
Secondary outcome [2] 0 0
Time from randomization to development of new metastatic lesions
Timepoint [2] 0 0
At approximately end of year 6 (study completion)
Secondary outcome [3] 0 0
Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire
Timepoint [3] 0 0
At approximately end of year 6 (study completion)
Secondary outcome [4] 0 0
Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
Timepoint [4] 0 0
At approximately end of year 6 (study completion)
Secondary outcome [5] 0 0
Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Timepoint [5] 0 0
End of years 1, 2, 3, 4, 5, and 6 (study completion)
Secondary outcome [6] 0 0
Overall Survival at midpoint of Study
Timepoint [6] 0 0
At approximately year 3 (midpoint)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amsterdam
Country [6] 0 0
Switzerland
State/province [6] 0 0
Zürich
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Edinburgh
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Other
Name
David Palma
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Amsterdam University Medical Centre, VUmc Site
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
British Columbia Cancer - Centre for the North
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Beaston West of Scotland Cancer Centre
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
London Health Sciences Centre
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Palma, MD
Address 0 0
London Health Sciences Centre, Lawson Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03721341