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

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

Interventions

RADIATION

Palliative 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.

DRUG

Chemotherapy

Chemotherapy may be given as indicated.

DRUG

Immunotherapy

Immunotherapy may be given as indicated.

DRUG

Hormones

Hormones may be given as indicated.

OTHER

Observation

Observation only is acceptable if this is the standard practice.

RADIATION

Stereotactic Ablative Radiotherapy

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).

Sponsors & Collaborators

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

  collaborator OTHER

• British Columbia Cancer - Centre for the North

  collaborator UNKNOWN

• Beaston West of Scotland Cancer Centre

  collaborator UNKNOWN

• London Health Sciences Centre

  collaborator OTHER

• David Palma

  lead OTHER

Principal Investigators

• David Palma, MD · London Health Sciences Centre, Lawson Health Research Institute

• Suresh Senan, MRCP, FRCR · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Robert Olson, MD · British Columbia Cancer - Centre for the North

• Stephen Harrow, MB ChB · Beaston West of Scotland Cancer Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-22

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• Australia
• Canada
• Netherlands
• Switzerland
• United Kingdom

Study Locations