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

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ClinicalTrials.gov Identifier: NCT01279408
Recruitment Status : Recruiting
First Posted : January 19, 2011
Last Update Posted : December 29, 2016
Information provided by (Responsible Party):
University Health Network, Toronto

January 17, 2011
January 19, 2011
December 29, 2016
November 2010
November 2017   (Final data collection date for primary outcome 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 [ Time Frame: 6 years ]
Same as current
Complete list of historical versions of study NCT01279408 on ClinicalTrials.gov Archive Site
  • To describe the patient reported outcomes (symptoms, toxicities and quality of life measures) in patients with ACLA-NSCLC at 4 and 12 months [ Time Frame: 6 years ]
  • To explore the relationship between utility and initial treatment decision (immediate versus deferred) [ Time Frame: 6 years ]
  • To describe the disease status (as per CT imaging) at 4 months [ Time Frame: 6 years ]
  • To describe the overall survival in patients with ACLA-NSCLC [ Time Frame: 6 years ]
Same as current
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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.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with Centrally Located Advanced NSCLC who are Asymptomatic and who are not Suitable for Curative Treatment
Non-small Cell Lung Carcinoma
Other: 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2017
November 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Rebecca Wong, MBChB 416 946 4501 ext 2126 Rebecca.Wong@rmp.uhn.on.ca
UHN REB 10-0484-CE
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University Health Network, Toronto
University Health Network, Toronto
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Principal Investigator: Rebecca Wong, MBChB University Health Network, Princess Margaret Hospital
University Health Network, Toronto
December 2016