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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01279408
Collaborator
(none)
46
1
216
0.2

Study Details

Study Description

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 Phase
  • Other: None: Questionnaire Study

Study Design

Study Type:
Observational
Actual Enrollment :
46 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
Actual Study Start Date :
Nov 1, 2010
Anticipated Primary Completion Date :
Nov 1, 2028
Anticipated Study Completion Date :
Nov 1, 2028

Outcome Measures

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 [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 [6 years]

  2. To explore the relationship between utility and initial treatment decision (immediate versus deferred) [6 years]

  3. To describe the disease status (as per CT imaging) at 4 months [6 years]

  4. To describe the overall survival in patients with ACLA-NSCLC [6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Health Network, Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Rebecca Wong, MBChB, University Health Network, Princess Margaret Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01279408
Other Study ID Numbers:
  • UHN REB 10-0484-CE
First Posted:
Jan 19, 2011
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021

Study Results

No Results Posted as of Oct 6, 2021