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Prospective Observational Study Of Patients With Asymptomatic Centrally Located Advanced NSCLC Who Are Not Suitable For Curative Treatment


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Carcinoma

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Trial Information

Prospective Observational Study Of Patients With Asymptomatic Centrally Located Advanced NSCLC Who Are Not Suitable For Curative Treatment


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Rebecca Wong, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 10-0484-CE

NCT ID:

NCT01279408

Start Date:

November 2010

Completion Date:

November 2015

Related Keywords:

  • Non-Small Cell Lung Carcinoma
  • Palliative treatment
  • advanced non-small cell lung cancer
  • Patients with Asymptomatic Centrally Located Advance NSCLC who are palliative
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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