Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01446744




Registration number
NCT01446744
Ethics application status
Date submitted
29/09/2011
Date registered
5/10/2011
Date last updated
5/10/2023

Titles & IDs
Public title
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)
Scientific title
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
Secondary ID [1] 0 0
SABR-COMET
Secondary ID [2] 0 0
R-11-605
Universal Trial Number (UTN)
Trial acronym
SABR-COMET
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 - Stereotactic ablative radiotherapy
Treatment: Other - palliative radiotherapy

Active comparator: Standard arm - Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Experimental: Stereotactic arm - Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist


Treatment: Other: Stereotactic ablative radiotherapy
Total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks.

Treatment: Other: palliative radiotherapy
Investigators should follow the principles of palliative radiotherapy as per the individual institution. Treatment recommendations are as follows:

Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions

Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions

Bone: Palliative radiotherapy as per 2011 consensus guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions

Liver: 20 Gy in 5 fractions if standard institutional practice
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
At approximately end of year 4 (study completion)
Secondary outcome [1] 0 0
Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)
Timepoint [1] 0 0
At approximately end of year 2, and end of year 4 (study completion)
Secondary outcome [2] 0 0
Toxicity: Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)
Timepoint [2] 0 0
At approximately the end of years 1, 2, 3, and 4 (study completion)
Secondary outcome [3] 0 0
Progression-free survival
Timepoint [3] 0 0
At approximately end of year 2, and end of year 4 (study completion)
Secondary outcome [4] 0 0
Lesional control rate
Timepoint [4] 0 0
At approximately end of year 2, and end of year 4 (study completion)
Secondary outcome [5] 0 0
Number of cycles of further chemotherapy/systemic therapy
Timepoint [5] 0 0
At approximately end of year 2, and end of year 4 (study completion)

Eligibility
Key inclusion criteria
* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
* ECOG performance status 0-1
* Controlled primary tumor

a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
* All sites of disease can be safely treated based on criteria below
* Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
* Life expectancy >6 months
* Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
* Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
* Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):

a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment

a. If that previously treated metastasis is NOT controlled on imaging:
1. If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
2. If the previous treatment was radiotherapy or RFA, the patient is ineligible.
* Patient presented at multidisciplinary tumor board or quality-assurance rounds.
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
* Bone metastasis in a femoral bone
* Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
* Prior radiotherapy to a site requiring treatment
* Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
* Malignant pleural effusion
* Inability to treat all sites of active disease
* Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
* Dominant brain metastasis requiring surgical decompression
* 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 2
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
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health, William Burkland Radiotherapy Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - 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
Prince Edward Island
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Netherlands
State/province [6] 0 0
Amsterdam
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Other
Name
Lawson Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
London Regional Cancer Program, Canada
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
VU University of Amsterdam
Address [2] 0 0
Country [2] 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, PhD
Address 0 0
London Regional Cancer Program of the 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

No information has been provided regarding IPD availability


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/NCT01446744