Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Lawson Health Research Institute
Sponsor:
Collaborators:
London Regional Cancer Program, Canada
VU University of Amsterdam
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01446744
First received: September 29, 2011
Last updated: May 8, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446744

Contacts
Contact: David Palma, MD, PhD 519-685-8650 David.Palma@lhsc.on.ca

Locations
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
Juravinski Cancer Centre, Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact    905-387-9711 ext 64706    anand.swaminath@jcc.hhsc.ca   
Principal Investigator: Anand Swaminath, MSc,MD,FRCPC         
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         
Sponsors and Collaborators
Lawson Health Research Institute
London Regional Cancer Program, Canada
VU University of Amsterdam
Investigators
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: May 8, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 24, 2014