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

• Sponsor: Ontario Clinical Oncology Group (OCOG) (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01968941
• Collaborator: Canadian Cancer Society (CCS) (Other)
• Enrollment: 324
• Locations: 16
• Arms: 2
• Anticipated Duration (Months): 96.8
• Patients Per Site: 20.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: Stereotactic Body Radiotherapy (SBRT); Radiation: Conventional Radiotherapy (CRT)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
• Actual Study Start Date: May 7, 2014
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stereotactic Body Radiotherapy Stereotactic Body Radiotherapy (SBRT)	Radiation: Stereotactic Body Radiotherapy (SBRT)
Active Comparator: Conventional Radiotherapy Conventional Radiotherapy (CRT)	Radiation: Conventional Radiotherapy (CRT)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. Lung Cancer-Specific Survival [5 years]

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

5. 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

6. 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.

7. 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.

8. Cost-Utility [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Centre	Calgary	Alberta	Canada
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	Cancer Care Manitoba	Winnipeg	Manitoba	Canada
4	Horizon Health Network	Saint John	New Brunswick	Canada
5	Juravinski Hospital and Cancer Centre	Hamilton	Ontario	Canada
6	Cancer Centre of Southeastern Ontario at the Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
7	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada
8	Niagara Health System-Walker Family Cancer Centre	St. Catharines	Ontario	Canada
9	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada
10	Windsor Regional Cancer Centre	Windsor	Ontario	Canada
11	Charles LeMoyne Hospital	Greenfield Park	Quebec	Canada	J4V 2H1
12	CHUM Hospital Notre Dame	Montreal	Quebec	Canada
13	Hôpital Maisonneuve-Rosemont	Montreal	Quebec	Canada
14	Montreal General Hospital McGill	Montreal	Quebec	Canada
15	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
16	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada

Sponsors and Collaborators

• Ontario Clinical Oncology Group (OCOG)
• Canadian Cancer Society (CCS)

Investigators

• Principal Investigator: Anand Swaminath, Ontario Clinical Oncology Group (OCOG)
• Principal Investigator: Tim Whelan, Ontario Clinical Oncology Group (OCOG)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT01968941
• Other Study ID Numbers: OCOG-2013-LUSTRE
• First Posted: Oct 24, 2013
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ontario Clinical Oncology Group (OCOG): stereotactic body radiotherapy; conventional radiotherapy; inoperable patients; local control; cancer recurrence; toxicity; survival
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 5, 2022