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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Primary Purpose

Metastatic Tumors

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Palliative Radiation

Chemotherapy

Immunotherapy

Hormones

Observation

Stereotactic Ablative Radiotherapy

About this trial

This is an interventional treatment trial for Metastatic Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Alfred HealthRecruiting
BC Cancer Agency, Vancouver Island CentreRecruiting
Nova Scotia Health AuthortiyRecruiting
Grand River HospitalRecruiting
London Regional Cancer Program of the Lawson Health Research InstituteRecruiting
Trillium Health Partners-Credit Valley Hospital
Niagra Health SystemRecruiting
Health Sciences NorthRecruiting
University Health NetworkRecruiting
Centre hospitalier de l'Université de Montréal-CHUMRecruiting
VU University Medical CentreRecruiting
University Hospital of ZürichRecruiting
Western General HospitalRecruiting
Beatson West of Scotland Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard arm

Stereotactic Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival at Study Completion

Time from randomization to death from any cause.

Secondary Outcome Measures

Progression-free Survival

Time from randomization to disease progression at any site or death.

Time from randomization to development of new metastatic lesions

New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.

Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire

Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire

Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Overall Survival at midpoint of Study

Full Information

NCT ID

NCT03721341

First Posted

October 23, 2018

Last Updated

October 13, 2022

Sponsor

David Palma

Collaborators

Amsterdam University Medical Centre, VUmc Site, British Columbia Cancer - Centre for the North, Beaston West of Scotland Cancer Centre, London Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT03721341

Brief Title

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

Acronym

SABR-COMET 10

Official Title

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 22, 2019 (Actual)

Primary Completion Date

January 2029 (Anticipated)

Study Completion Date

January 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Palma

Collaborators

Amsterdam University Medical Centre, VUmc Site, British Columbia Cancer - Centre for the North, Beaston West of Scotland Cancer Centre, London Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Stereotactic Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Palliative Radiation

Other Intervention Name(s)

Palliative Radiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Chemotherapy may be given as indicated.

Intervention Type

Drug

Intervention Name(s)

Immunotherapy

Intervention Description

Immunotherapy may be given as indicated.

Intervention Type

Drug

Intervention Name(s)

Hormones

Intervention Description

Hormones may be given as indicated.

Intervention Type

Other

Intervention Name(s)

Observation

Intervention Description

Observation only is acceptable if this is the standard practice.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Ablative Radiotherapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Overall Survival at Study Completion

Description

Time from randomization to death from any cause.

Time Frame

At approximately end of year 6 (study completion)

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

Time from randomization to disease progression at any site or death.

Time Frame

At approximately year 3, and end of year 6 (study completion)

Title

Time from randomization to development of new metastatic lesions

Description

New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.

Time Frame

At approximately end of year 6 (study completion)

Title

Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire

Time Frame

At approximately end of year 6 (study completion)

Title

Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire

Time Frame

At approximately end of year 6 (study completion)

Title

Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time Frame

End of years 1, 2, 3, 4, 5, and 6 (study completion)

Title

Overall Survival at midpoint of Study

Time Frame

At approximately year 3 (midpoint)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Palma, MD

Phone

519-685-8650

David.Palma@lhsc.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Palma, MD

Organizational Affiliation

London Health Sciences Centre, Lawson Health Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suresh Senan, MRCP, FRCR

Organizational Affiliation

Amsterdam University Medical Centre, VUmc Site

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Olson, MD

Organizational Affiliation

British Columbia Cancer - Centre for the North

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephen Harrow, MB ChB

Organizational Affiliation

Beaston West of Scotland Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alfred Health

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robin Smith

Phone

61-3-9076-2360

r.smith@alfred.org.au

First Name & Middle Initial & Last Name & Degree

Carole Owens

Phone

03 90762174

c.owens@alfred.org.au

First Name & Middle Initial & Last Name & Degree

Sashendra Senthi

Facility Name

BC Cancer Agency, Vancouver Island Centre

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 4X1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shyann Hoppe, RN BScN

First Name & Middle Initial & Last Name & Degree

Emily White

First Name & Middle Initial & Last Name & Degree

Tanya S Berrang, FRCPC

Facility Name

Nova Scotia Health Authortiy

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3S 0H6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robin Simpson

Robin.Simpson@nshealth.ca

First Name & Middle Initial & Last Name & Degree

Kim Pitts

Kim.Pitts@nshealth.ca

First Name & Middle Initial & Last Name & Degree

Liam Mulroy

Facility Name

Grand River Hospital

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla Girolametto

Phone

519-749-4300

Ext

2307

carla.girolametto@grhosp.on.ca

First Name & Middle Initial & Last Name & Degree

Elyse Wellhauser

Phone

519-749-4370

Ext

2447

Elyse.Wellhauser@grhosp.on.ca

First Name & Middle Initial & Last Name & Degree

Darin Gopaul, FRCPC

Facility Name

London Regional Cancer Program of the Lawson Health Research Institute

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Palma, MD

Phone

519-685-8650

David.Palma@lhsc.on.ca

First Name & Middle Initial & Last Name & Degree

David Palma, MD, PhD

Facility Name

Trillium Health Partners-Credit Valley Hospital

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2N1

Country

Canada

Individual Site Status

Suspended

Facility Name

Niagra Health System

City

St. Catharines

State/Province

Ontario

ZIP/Postal Code

L2S 0A9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Coreen Corning

Phone

905 684-7271

Ext

45703

Coreen.Corning@niagarahealth.on.ca

First Name & Middle Initial & Last Name & Degree

Khadija Al-Harazi

Phone

905 684-7271

Ext

45703

Khadija.Al-Harazi@niagarahealth.on.ca

First Name & Middle Initial & Last Name & Degree

Abhirami Hallock, FRCPC

Facility Name

Health Sciences North

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Ricard

Phone

705-522-6237

Ext

2615

laricard@hsnsudbury.ca

First Name & Middle Initial & Last Name & Degree

Andrew Pearce

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessy Abed, MRT(T), MHSc.

Phone

416-946-4501

Ext

5881

Jessy.Abed@rmp.uhn.ca

First Name & Middle Initial & Last Name & Degree

William Tang

Phone

416-946-4501

william.tang@RMP.uhn.ca

First Name & Middle Initial & Last Name & Degree

Aisling Barry, MRCPI,FFRRCSI

First Name & Middle Initial & Last Name & Degree

Meredith Giuliani, MBBS,FRCPC

Facility Name

Centre hospitalier de l'Université de Montréal-CHUM

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diane Trudel, RN

Phone

514-890-8000

Ext

11181

diane.dt.trudel.chum@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Chantal Lafleur

Phone

514-890-8000

chantal.lafleur.chum@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Houda Bahig

First Name & Middle Initial & Last Name & Degree

Philip Wong

Facility Name

VU University Medical Centre

City

Amsterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suresh Senan

Phone

+31-20-444 1571

s.senan@vumc.nl

First Name & Middle Initial & Last Name & Degree

Famke Scheiders

Phone

020- 444 5851/ 020- 444 1571

f.schneiders@amsterdamumc.nl

Facility Name

University Hospital of Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cornelia Schaefer

Phone

41 44 255 37 68

Cornelia.Schaefer@usz.ch

First Name & Middle Initial & Last Name & Degree

Matthias Guckenberge

Facility Name

Western General Hospital

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magdalena Patrzalek

Magdalena.Patrzalek@nhslothian.scot.nhs.uk

First Name & Middle Initial & Last Name & Degree

Stephen Harrow

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Nicol

Phone

0044(0)1413017223

Maria.Nicol@ggc.scot.nhs.uk

First Name & Middle Initial & Last Name & Degree

Austin McInnes

Phone

0044(0)1413017223

Austin.McInnes@Glasgow.ac.uk

First Name & Middle Initial & Last Name & Degree

Stephen McKay, FRCR

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33608212

Citation

Mattes MD, Eubank TD, Almubarak M, Wen S, Marano GD, Jacobson GM, Ma PC. A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2021 Jul;22(4):268-273. doi: 10.1016/j.cllc.2021.01.012. Epub 2021 Jan 25.

Results Reference

derived

PubMed Identifier

31426760

Citation

Palma DA, Olson R, Harrow S, Correa RJM, Schneiders F, Haasbeek CJA, Rodrigues GB, Lock M, Yaremko BP, Bauman GS, Ahmad B, Schellenberg D, Liu M, Gaede S, Laba J, Mulroy L, Senthi S, Louie AV, Swaminath A, Chalmers A, Warner A, Slotman BJ, de Gruijl TD, Allan A, Senan S. Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial. BMC Cancer. 2019 Aug 19;19(1):816. doi: 10.1186/s12885-019-5977-6.

Results Reference

derived

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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

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