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

NCT03721341 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SABR-COMET 10
• Study Type: interventional
• Target: 204
• Locations: 5 countries
• Sites: 14

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.

Conditions

Metastatic Tumors

Outcome Measures

Primary Outcomes (1)

• Overall Survival at Study Completion

  Time from randomization to death from any cause.

  At approximately end of year 6 (study completion)

Secondary Outcomes (6)

• Progression-free Survival

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

• Time from randomization to development of new metastatic lesions

  At approximately end of year 6 (study completion)

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

  At approximately end of year 6 (study completion)

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

  At approximately end of year 6 (study completion)

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

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

Study Arms (2)

Standard arm

ACTIVE COMPARATOR

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

Radiation: Palliative Radiation; Drug: Chemotherapy; Drug: Immunotherapy; Drug: Hormones; Other: Observation

Stereotactic Arm

EXPERIMENTAL

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

Drug: Chemotherapy; Drug: Immunotherapy; Drug: Hormones; Other: Observation; Radiation: Stereotactic Ablative Radiotherapy

Interventions

Palliative Radiation RADIATION

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.

Also known as: Palliative Radiotherapy

Standard arm

Chemotherapy DRUG

Chemotherapy may be given as indicated.

Standard arm; Stereotactic Arm

Immunotherapy DRUG

Immunotherapy may be given as indicated.

Standard arm; Stereotactic Arm

Hormones DRUG

Hormones may be given as indicated.

Standard arm; Stereotactic Arm

Observation OTHER

Observation only is acceptable if this is the standard practice.

Standard arm; Stereotactic Arm

Stereotactic Ablative Radiotherapy RADIATION

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).

Stereotactic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Palma: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• British Columbia Cancer - Centre for the North: collaborator
• Beaston West of Scotland Cancer Centre: collaborator
• London Health Sciences Centre: collaborator

Study Sites (14)

Alfred Health

Melbourne, Victoria, 3181, Australia

Location

BC Cancer Agency, Vancouver Island Centre

Victoria, British Columbia, V8R 4X1, Canada

Location

Nova Scotia Health Authortiy

Halifax, Nova Scotia, B3S 0H6, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 5W9, Canada

Location

Trillium Health Partners-Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Niagra Health System

St. Catharines, Ontario, L2S 0A9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Centre hospitalier de l'Université de Montréal-CHUM

Montreal, Quebec, H2X 0C1, Canada

Location

VU University Medical Centre

Amsterdam, Netherlands

Location

University Hospital of Zürich

Zurich, 8091, Switzerland

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33608212 DERIVED

• 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.

  PMID: 31426760 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Drug Therapy; Immunotherapy; Hormones; Observation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Methods; Investigative Techniques

Study Officials

• David Palma, MD

  London Health Sciences Centre, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

• Suresh Senan, MRCP, FRCR

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Robert Olson, MD

  British Columbia Cancer - Centre for the North

  PRINCIPAL INVESTIGATOR

• Stephen Harrow, MB ChB

  Beaston West of Scotland Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 26, 2018
• Study Start: February 22, 2019
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); CH (1); GB (2); AU (1); NL (1)