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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446744
Recruitment Status : Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
London Regional Cancer Program, Canada
VU University of Amsterdam
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE September 29, 2011
First Posted Date  ICMJE October 5, 2011
Last Update Posted Date August 20, 2019
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
Overall Survival [ Time Frame: At approximately end of year 4 (study completion) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2011)
  • Quality of life [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Toxicity [ Time Frame: At approximately the end of years 1, 2, 3, and 4 (study completion) ]
  • Progression-free survival [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Lesional control rate [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Number of cycles of further chemotherapy/systemic therapy [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
  • Quality of life [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Toxicity [ Time Frame: Annually ]
  • Progression-free survival [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Lesional control rate [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
  • Number of cycles of further chemotherapy/systemic therapy [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)
Official Title  ICMJE Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
Brief Summary 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.
Detailed Description

TREATMENT PLAN

6.0.1 Standard Arm (Arm 1)

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Patients in this arm should not receive stereotactic doses or radiotherapy boosts.

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

6.0.2 Treatment Planning for Standard Arm

Treatment planning is to be done using CT simulation or conventional simulation (fluoroscopy) as per individual institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible.

6.1 Experimental Arm (Arm 2)

All treatments in this study are based on current protocols in clinical use at the LRCP and VUmc for treatment of lung,17 liver,18 brain,19,20 and spinal cord21 metastases. The guiding principle for radiotherapy is to achieve disease control but to minimize any potential adverse impact on quality of life. Concurrent chemotherapy or targeted therapy at the time of radiotherapy is not permitted within the 4 weeks prior to SABR. Hormone therapy is permitted.

6.1.1 Dose/Fractionation

Lung- tumors 3 cm or less surrounded by lung parenchyma, 54(Gy) in 3 fractions

  • Abutting chest wall or >3 cm, 55(Gy)in 5 fractions, every second day
  • Within 2 cm of mediastinum or brachial plexus, 60(Gy),8* fractions, every second day

Bone -Any bone except femur,35(Gy), in 5 fractions,daily

  • vertebral body,16-20(Gy)in 1 fraction, single dose, or 30Gy in 3 fractions, every second day

Brain - Non-radiosurgical,40(Gy) to metastases, in 5 fractions,daily

  • If whole brain treated, then simultaneous boost to each lesion,20 Gy whole brain (optional), in 5 fractions, daily
  • Radiosurgical, ≤1 cm, 22-24(Gy), in 1 fraction, >1 and ≤2 cm, 22-24(Gy) in 1 fraction >2 and ≤ 3 cm, 18-20(Gy) in 1 fraction Optional whole brain to follow (see text) Liver-LRCP site: Dose is based on calculated normal tissue probability of <5%,Every second day
  • other sites 45-60(Gy), in 3-8 fractions, every second day

Adrenal, 60 (Gy), in 8 fractions, every second day

(If whole brain treated, then simultaneous boost to each lesion)

6.1.2 Immobilization

Treatment will be setup using reproducible positioning, verified using an on-line protocol, for all patients in this study. Immobilization may include a custom immobilization device, such as thermoplastic shell or vac-lok bag, as per individual institutional practice when delivering SABR. Some centers do not use immobilization devices and have demonstrated high degrees of accuracy; this is acceptable in this study.

6.1.3 Imaging/Localization/Registration All patients in Arm 2 will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. Axial CT images will be obtained throughout the region of interest. For centres using stereotactic radiosurgery platforms, real-time tumor tracking and orthogonal imaging systems are permitted.

Any center which is not yet experienced in lesions at any specific sub-site (e.g. adrenal metastases) shall be eligible to participate by including only patients with lesions at other pre-specified sites

It is strongly recommended that the doses to organs at risk are not to be exceeded - in some specific cases, this may require lower doses or higher fractionations than listed here. Such changes in dose will require approval of one of the local principal investigators. (see section 6.2)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Tumors
Intervention  ICMJE
  • 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.
  • 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

Study Arms  ICMJE
  • Active Comparator: Standard arm
    Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
    Intervention: Radiation: palliative radiotherapy
  • Experimental: Stereotactic arm
    Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
    Intervention: Radiation: Stereotactic ablative radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 3, 2011)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446744
Other Study ID Numbers  ICMJE R-11-605
SABR-COMET ( Other Identifier: OCREB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Palma, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE
  • London Regional Cancer Program, Canada
  • VU University of Amsterdam
Investigators  ICMJE
Principal Investigator: David Palma, MD, PhD London Regional Cancer Program of the Lawson Health Research Institute
Principal Investigator: Suresh Senan, MRCPFRCR,PhD VU University Medical Center
PRS Account Lawson Health Research Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP