Clinical trial NCT01279408: Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)
Official title: Prospective Observational Study Of Patients With Asymptomatic Centrally Located Advanced NSCLC Who Are Not Suitable For Curative Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Centrally Located Advanced NSCLC who are Asymptomatic and who are not Suitable for Curative Treatment

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.


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)

Primary outcomes:
measure: 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
timeFrame: 6 years
Secondary outcomes:
measure: To describe the patient reported outcomes (symptoms, toxicities and quality of life measures) in patients with ACLA-NSCLC at 4 and 12 months
timeFrame: 6 years
measure: To explore the relationship between utility and initial treatment decision (immediate versus deferred)
timeFrame: 6 years
measure: To describe the disease status (as per CT imaging) at 4 months
timeFrame: 6 years
measure: To describe the overall survival in patients with ACLA-NSCLC
timeFrame: 6 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Rebecca Wong, MBChB
role: PRINCIPAL_INVESTIGATOR
References: