Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
NCT ID: NCT01968941
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2014-05-07
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
Stereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy
Conventional Radiotherapy (CRT)
Conventional Radiotherapy (CRT)
Interventions
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Stereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy (CRT)
Eligibility Criteria
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Inclusion Criteria
2. Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems \[e.g. chronic obstructive pulmonary disease (COPD), heart disease\], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk.
Exclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
3. Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer).
4. History of ataxia telangiectasia.
5. Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur.
6. Previous pneumonectomy with Stage I lung cancer in the remaining lung.
7. Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease.
8. Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
9. Female, who is currently pregnant or lactating.
10. Geographic inaccessibility for follow-up.
11. Unable to provide informed consent.
18 Years
ALL
No
Sponsors
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Canadian Cancer Society (CCS)
OTHER
Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Anand Swaminath
Role: PRINCIPAL_INVESTIGATOR
Ontario Clinical Oncology Group (OCOG)
Tim Whelan
Role: PRINCIPAL_INVESTIGATOR
Ontario Clinical Oncology Group (OCOG)
Locations
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Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Horizon Health Network
Saint John, New Brunswick, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at the Kingston General Hospital
Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Niagara Health System-Walker Family Cancer Centre
St. Catharines, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada
CHUM Hospital Notre Dame
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Montreal General Hospital McGill
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.
Other Identifiers
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OCOG-2013-LUSTRE
Identifier Type: -
Identifier Source: org_study_id
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