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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00643396
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : February 26, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cel Lung Cancer Radiation: thoracic radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Study Start Date : February 2008
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. local control [ Time Frame: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment ]

Secondary Outcome Measures :
  1. radiotherapy toxicities [ Time Frame: 1-2 years after study treatment ]
  2. patient quality of life [ Time Frame: 1-2 years after study treatment ]
  3. overall survival [ Time Frame: 1-2 years after study treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00643396

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Principal Investigator: Don Yee, MD, FRCPC AHS Cancer Control Alberta

Responsible Party: AHS Cancer Control Alberta Identifier: NCT00643396     History of Changes
Other Study ID Numbers: LU-23929/23929
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: April 2012

Keywords provided by AHS Cancer Control Alberta:
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms