NCT01279408Completed
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 17 Jan 2011
- Start date
- Nov 2010
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Lung cancer
- NCT number
- NCT01279408
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From Nov 2010 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Intra-thoracic disease is peripheral only, not extending within 2cm of trachea/proximal bronchial tree
- Histological diagnosis of small cell lung cancer, or malignant mediastinal lymphadenopathy from another malignancy (not NSCLC)
Other
- Symptomatic from intra-thoracic NSCLC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.