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Hypofractionated Radiotherapy for Limited 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: NCT00907569
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : February 22, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Neoplasm Small Cell Carcinoma Radiation: Hypofractionated Chest Radiotherapy Phase 2

Detailed Description:
The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
Study Start Date : June 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Radiation: Hypofractionated Chest Radiotherapy
    Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.

Primary Outcome Measures :
  1. 2-year overall survival [ Time Frame: 2011 ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2011 ]
  2. Patterns of Failure [ Time Frame: 2011 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • limited stage small cell lung cancer
  • adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
  • signed study consent
  • age at least 18 years
  • Karnofsky performance status as least 70%
  • eligible to receive standard concurrent small cell cancer chemotherapy

Exclusion Criteria:

  • extensive stage disease
  • mixed non small cell and small cell histology
  • inadequate pulmonary function tests
  • not eligible for concurrent chemotherapy
  • subtotal or total tumor resection
  • previous chest/neck radiotherapy
  • prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
  • pregnant
  • prior chemotherapy for another malignancy
  • patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

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): NCT00907569

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00907569    
Other Study ID Numbers: 24762
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: September 2011
Keywords provided by AHS Cancer Control Alberta:
Small cell lung cancer
radiotherapy dose escalation
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type