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

NCT01279408 | Completed

• 1 other identifier: 10-0484
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Carcinoma

Keywords

Palliative treatment; advanced non-small cell lung cancer; Patients with Asymptomatic Centrally Located Advance NSCLC who are palliative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

None: Questionnaire Study OTHER

Patients enrolled in this study will have standard treatment as per the discretion of their attending physician. The only additional requirement is that they would be asked is to complete questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rebecca Wong, MBChB

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CA (1)