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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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Carcinoma Other: None: Questionnaire Study

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study Of Patients With Asymptomatic Centrally Located Advanced NSCLC Who Are Not Suitable For Curative Treatment
Study Start Date : November 2010
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  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 [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. To explore the relationship between utility and initial treatment decision (immediate versus deferred) [ Time Frame: 6 years ]
  3. To describe the disease status (as per CT imaging) at 4 months [ Time Frame: 6 years ]
  4. To describe the overall survival in patients with ACLA-NSCLC [ Time Frame: 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Centrally Located Advanced NSCLC who are Asymptomatic and who are not Suitable for Curative Treatment
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279408


Contacts
Contact: Rebecca Wong, MBChB 416 946 4501 ext 2126 Rebecca.Wong@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Rebecca Wong, MBChB    416 946 4501 ext 2126    Rebecca.Wong@rmp.uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Rebecca Wong, MBChB University Health Network, Princess Margaret Hospital

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01279408     History of Changes
Other Study ID Numbers: UHN REB 10-0484-CE
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by University Health Network, Toronto:
Palliative treatment
advanced non-small cell lung cancer
Patients with Asymptomatic Centrally Located Advance NSCLC who are palliative

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms