NCT01446744

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
1mo left

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
4 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

14.6 years

First QC Date

September 29, 2011

Last Update Submit

October 4, 2023

Conditions

Metastatic Tumors

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    At approximately end of year 4 (study completion)

Secondary Outcomes (5)

  • Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)

    At approximately end of year 2, and end of year 4 (study completion)

  • Toxicity: Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)

    At approximately the end of years 1, 2, 3, and 4 (study completion)

  • Progression-free survival

    At approximately end of year 2, and end of year 4 (study completion)

  • Lesional control rate

    At approximately end of year 2, and end of year 4 (study completion)

  • Number of cycles of further chemotherapy/systemic therapy

    At approximately end of year 2, and end of year 4 (study completion)

Study Arms (2)

Standard arm

ACTIVE COMPARATOR

Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Radiation: palliative radiotherapy

Stereotactic arm

EXPERIMENTAL

Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Radiation: Stereotactic ablative radiotherapy

Interventions

Stereotactic ablative radiotherapyRADIATION

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.

Stereotactic arm
palliative radiotherapyRADIATION

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

Standard arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Alfred Health, William Burkland Radiotherapy Centre

Melbourne, Victoria, 3004, Australia

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

Atlantic Clinical Cancer Research , QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre, Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Ottawa Cancer Centre

Ottawa, Ontario, Canada

Location

PEI Cancer Treatment Center

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

McGill University Health Centre Research Institute

Montreal, Quebec, H3H 1A4, Canada

Location

VU University Amsterdam (VUmc)

Amsterdam, Netherlands

Location

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Related Publications (3)

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

    PMID: 32484754DERIVED

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.

    PMID: 30982687DERIVED

  • Palma DA, Haasbeek CJ, Rodrigues GB, Dahele M, Lock M, Yaremko B, Olson R, Liu M, Panarotto J, Griffioen GH, Gaede S, Slotman B, Senan S. Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): study protocol for a randomized phase II trial. BMC Cancer. 2012 Jul 23;12:305. doi: 10.1186/1471-2407-12-305.

    PMID: 22823994DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Palma, MD, PhD

    London Regional Cancer Program of the Lawson Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Suresh Senan, MRCPFRCR,PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 5, 2011

Study Start

November 1, 2011

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

GB(1)AU(1)CA(7)NL(1)