Non-small Cell Lung Cancer Clinical Trial
— LUSTREOfficial title:
A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
Verified date | September 2022 |
Source | Ontario Clinical Oncology Group (OCOG) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Ontario Clinical Oncology Group (OCOG) | Canadian Cancer Society (CCS) |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |