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

NCT ID: NCT01279408

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2028-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

None: Questionnaire Study

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Wong, MBChB

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 10-0484-CE

Identifier Type: -

Identifier Source: org_study_id