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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00643396
First received: March 24, 2008
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Extensive Stage Small Cel Lung Cancer
 Radiation: thoracic radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:

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

Further study details as provided by Alberta Health Services:

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

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643396

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Don Yee, MD, FRCPC Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00643396     History of Changes
Other Study ID Numbers: LU-23929/23929
Study First Received: March 24, 2008
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
small cell lung cancer
radiotherapy

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

ClinicalTrials.gov processed this record on May 23, 2013