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

Phase 3CompletedNCT01968941

Ontario Clinical Oncology Group (OCOG)324 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

324

Conditions

Non-small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

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

...and 6 more locations

Outcomes

Primary Outcomes

Local Control

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.

Time frame: 5 years

Secondary Outcomes

Overall Survival

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.

Time frame: 5 years

Disease-Free Survival

Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.

Time frame: 5 years

Event-Free Survival

Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.

Time frame: 5 years

Lung Cancer-Specific Survival

Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer

Time frame: 5 years

Radiation Treatment-Related Death

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

Time frame: 1 to 12 months

Toxicity

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.

Time frame: 5 years

Quality of Life

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.

Time frame: 2 years

Cost-Utility

Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results

Time frame: 3 years