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

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: Stereotactic Body Radiotherapy (SBRT); Radiation: Conventional Radiotherapy (CRT)

• Registration Number: NCT01968941
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Study Start: 2014-05-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiotherapy	Stereotactic Body Radiotherapy (SBRT)	Stereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy	Conventional Radiotherapy (CRT)	Conventional Radiotherapy (CRT)

Primary Outcome Measures

Name	Time	Method
Local Control	5 years	Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure.

Secondary Outcome Measures

Name	Time	Method
Lung Cancer-Specific Survival	5 years	Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
Event-Free Survival	5 years	Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.
Disease-Free Survival	5 years	Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
Toxicity	5 years	Acute Toxicity will be assessed at 3 months post-randomization and includes fatigue, dyspnea and esophagitis. Late toxicity will be assessed beyond 3 months and up to 5 years and includes radiation pneumonitis, chest wall pain and rib fracture.
Overall Survival	5 years	Overall Survival is defined as the time from randomization to death from any cause. Alive subjects will be censored on the date of last follow-up.
Radiation Treatment-Related Death	1 to 12 months	Radiation Treatment-Related Death is defined as death occurring between 1 to 12 months following treatment, and caused directly by radiation toxicity attributed to either catastrophic hemorrhage or to severe radiation pneumonitis leading to death
Quality of Life	2 years	Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Lung Cancer-specific Module 13 questionnaires.
Cost-Utility	3 years	Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results

Trial Locations

Locations (16)

Cancer Centre of Southeastern Ontario at the Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Juravinski Hospital and Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Windsor Regional Cancer Centre; 🇨🇦 Windsor, Ontario, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Niagara Health System-Walker Family Cancer Centre; 🇨🇦 St. Catharines, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Charles LeMoyne Hospital; 🇨🇦 Greenfield Park, 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

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

CHUM Hospital Notre Dame; 🇨🇦 Montreal, Quebec, Canada

Horizon Health Network; 🇨🇦 Saint John, New Brunswick, Canada

Cancer Care Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada