Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)
Study Details
Study Description
Brief Summary
The aim of the study is to assess current practice within PROP & lung teams, for treating asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to observe outcomes for those patients receiving immediate or deferred RT. This is a prospective cohort trial. Patients will be managed by immediate radiotherapy (RT) or a deferred approach according to physicians' individual current clinical practice. Baseline and follow-up data collection will be structured to focus on patient-reported measures to describe clinical outcomes in the two management groups. Indications for prescribing RT and dose fractionation schedules will also be collected. A new intervention will not be introduced during this trial. Instead, a follow-up regimen will be offered to both groups of patients, so that RT can be offered to the deferred group of patients if/when symptoms develop, and we can monitor symptoms/toxicities and QoL in both groups of patients.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- To determine the pattern of practice for management (immediate radiotherapy, deferred radiotherapy) of patients with ACLA-NSCLC, including reasons, timing and dose fractionation of lung/mediastinal RT [6 years]
Secondary Outcome Measures
- To describe the patient reported outcomes (symptoms, toxicities and quality of life measures) in patients with ACLA-NSCLC at 4 and 12 months [6 years]
- To explore the relationship between utility and initial treatment decision (immediate versus deferred) [6 years]
- To describe the disease status (as per CT imaging) at 4 months [6 years]
- To describe the overall survival in patients with ACLA-NSCLC [6 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically confirmed NSCLC
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Central disease, as defined by tumour (either primary or nodal disease) arising or extending within a 2cm circumferential expansion from the centre of the trachea or within the zone of the proximal bronchial tree
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Disease is visible on thoracic CT (diagnostic or simulation)
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Asymptomatic from intra-thoracic tumour (may have background chest symptoms related to underlying COAD etc, but these symptoms must not have worsened due to tumour)
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Patient (due to age or co-morbidities) or tumour (due to locally advanced or metastatic disease) is not suitable for radical treatment (defined as surgery or RT dose >50Gy in 20 fractions or equivalent).
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Previous chemotherapy, thoracic RT or surgery is allowed
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RT to other metastases (e.g. brain, bone etc) is allowed
•≥ 18 years of age
- Able to provide written informed consent
Exclusion Criteria:
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Intra-thoracic disease is peripheral only, not extending within 2cm of trachea/proximal bronchial tree
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Symptomatic from intra-thoracic NSCLC
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Histological diagnosis of small cell lung cancer, or malignant mediastinal lymphadenopathy from another malignancy (not NSCLC)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Health Network, Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Rebecca Wong, MBChB, University Health Network, Princess Margaret Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UHN REB 10-0484-CE