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Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cel Lung Cancer

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Trial Information

Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer


Inclusion Criteria:



- Histologic or cytologic confirmation of small cell lung cancer

- extensive stage disease

- adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)

- patients of childbearing potential must practice adequate contraception

- age ≧ 18 years

- Karnofsky performance status ≧ 70

- documented objective response to initial chemotherapy

- signed study-specific informed consent form

Exclusion Criteria:

- complete or subtotal tumor resection

- non-small cell histology

- prior or concurrent malignancy except non-melanoma skin cancer unless disease-free
for at least 5 years

- prior chest or neck RT

- inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)

- pregnant

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

local control

Outcome Time Frame:

we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment

Principal Investigator

Don Yee, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

LU-23929/23929

NCT ID:

NCT00643396

Start Date:

February 2008

Completion Date:

January 2012

Related Keywords:

  • Extensive Stage Small Cel Lung Cancer
  • small cell lung cancer
  • radiotherapy
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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