Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)
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Purpose
Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Oligometastatic Tumors |
Radiation: Stereotactic ablative radiotherapy Radiation: palliative radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial |
- Overall Survival [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: At approximately the end of years 1, 2, 3, and 4 (study completion) ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ] [ Designated as safety issue: No ]
- Lesional control rate [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ] [ Designated as safety issue: No ]
- Number of cycles of further chemotherapy/systemic therapy [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 99 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | November 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard arm
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
|
Radiation: 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 |
|
Experimental: Stereotactic arm
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
|
Radiation: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
- If the previous treatment was radiotherapy or RFA, the patient is ineligible.
- Patient presented at multidisciplinary tumor board or quality-assurance rounds.
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
Contacts and Locations| Contact: David Palma, MD, PhD | 519-685-8650 | David.Palma@lhsc.on.ca |
| Canada, British Columbia | |
| BC Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada, V5Z4E6 | |
| Contact: Robert Olson, MSc,MD, FRCPC rolson2@bccancer.bc.ca | |
| Principal Investigator: Robert Olson, MSc,MD,FRCPC | |
| Canada, Ontario | |
| London Regional Cancer Program of the Lawson Health Research Institute | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca | |
| Principal Investigator: David Palma, MD, PhD | |
| Ottawa Cancer Centre | Not yet recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Jason Pantarotto, MD | |
| Principal Investigator: Jason Pantarotto, MD | |
| Northeast Cancer Centre, Health Sciences North | Recruiting |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Contact: Andrew Pearce, MD, MSc,FRCPC 705-522-6237 ext 2449 apearce@hsn.sudbury.ca | |
| Principal Investigator: Andrew Pearce, MSc,MD, FRCPC | |
| Netherlands | |
| VU University Amsterdam (VUmc) | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Suresh Senan, MRCP | |
| Principal Investigator: Suresh Senan, MRCP, FRCR, PhD | |
| Principal Investigator: | David Palma, MD, PhD | London Regional Cancer Program of the Lawson Health Research Institute |
| Principal Investigator: | Suresh Senan, MRCP, FRCR, PhD | VU University Medical Center, Amsterdam |
More Information
No publications provided by Lawson Health Research Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Palma, Principal Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01446744 History of Changes |
| Other Study ID Numbers: | R-11-605, SABR-COMET |
| Study First Received: | September 29, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
ClinicalTrials.gov processed this record on June 18, 2013