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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01279408
First received: January 17, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Non-small Cell Lung Carcinoma
Other: None: Questionnaire Study

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To explore the relationship between utility and initial treatment decision (immediate versus deferred) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To describe the disease status (as per CT imaging) at 4 months [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To describe the overall survival in patients with ACLA-NSCLC [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01279408     History of Changes
Other Study ID Numbers: UHN REB 10-0484-CE
Study First Received: January 17, 2011
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 20, 2014