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

Non-small Cell Lung Cancer Clinical Trial

— LUSTRE  

Official title:

A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968941
• Other study ID #: OCOG-2013-LUSTRE
• Status: Completed
• Phase: Phase 3
• Start date: May 7, 2014
• Est. completion date: May 2022

Study information

• Verified date: September 2022
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: May 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• Stereotactic Body Radiotherapy (SBRT)

• Conventional Radiotherapy (CRT)

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Charles LeMoyne Hospital	Greenfield Park	Quebec
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	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	Horizon Health Network	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
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	Cancer Care Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	Event-Free Survival	Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.	5 years
Secondary	Lung Cancer-Specific Survival	Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer	5 years
Secondary	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	1 to 12 months
Secondary	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.	5 years
Secondary	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.	2 years
Secondary	Cost-Utility	Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results	3 years