Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)

Active, not recruiting

• Conditions: Non-small Cell Lung Carcinoma

• Registration Number: NCT01279408
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-17
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Histologically or cytologically confirmed NSCLC

• 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

• Disease is visible on thoracic CT (diagnostic or simulation)

• 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)

• 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).

• Previous chemotherapy, thoracic RT or surgery is allowed

• RT to other metastases (e.g. brain, bone etc) is allowed

  •≥ 18 years of age

• Able to provide written informed consent

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Exclusion Criteria

• Intra-thoracic disease is peripheral only, not extending within 2cm of trachea/proximal bronchial tree
• Symptomatic from intra-thoracic NSCLC
• Histological diagnosis of small cell lung cancer, or malignant mediastinal lymphadenopathy from another malignancy (not NSCLC)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada