Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients

NCT ID: NCT01968941

Last Updated: 2022-09-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-07

Study Completion Date

2022-05-31

Brief Summary

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A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy (SBRT)

Group Type EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT)

Intervention Type RADIATION

Conventional Radiotherapy

Conventional Radiotherapy (CRT)

Group Type ACTIVE_COMPARATOR

Conventional Radiotherapy (CRT)

Intervention Type RADIATION

Interventions

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Stereotactic Body Radiotherapy (SBRT)

Intervention Type RADIATION

Conventional Radiotherapy (CRT)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
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

1. Less than 18 years of age.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

Horizon Health Network

Saint John, New Brunswick, Canada

Site Status

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Site Status

Cancer Centre of Southeastern Ontario at the Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Site Status

Niagara Health System-Walker Family Cancer Centre

St. Catharines, Ontario, Canada

Site Status

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Site Status

Charles LeMoyne Hospital

Greenfield Park, Quebec, Canada

Site Status

CHUM Hospital Notre Dame

Montreal, Quebec, Canada

Site Status

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Montreal General Hospital McGill

Montreal, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

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.

Reference Type DERIVED
PMID: 34561039 (View on PubMed)

Other Identifiers

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OCOG-2013-LUSTRE

Identifier Type: -

Identifier Source: org_study_id

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