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

Prospective Observational Study Of Patients With Asymptomatic Centrally Located Advanced NSCLC Who Are Not Suitable For Curative Treatment

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Carcinoma
• Intervention / Treatment: Other: None: Questionnaire Study

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Centrally Located Advanced NSCLC who are Asymptomatic and who are not Suitable for Curative Treatment

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Rebecca Wong, MBChB, University Health Network, Princess Margaret Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimated): January 19, 2011

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: advanced non-small cell lung cancer; Palliative treatment; Patients with Asymptomatic Centrally Located Advance NSCLC who are palliative
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 10-0484