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Pilot Project of Adaptive Thoracic Radiotherapy for 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.
ClinicalTrials.gov Identifier: NCT01426841
Recruitment Status : Unknown
Verified October 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2011
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):

April 15, 2011
September 1, 2011
October 2, 2014
August 2011
April 2015   (Final data collection date for primary outcome measure)
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach [ Time Frame: 12-24 months ]
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
Same as current
Complete list of historical versions of study NCT01426841 on ClinicalTrials.gov Archive Site
  • Local control and patterns of failure [ Time Frame: 12-24 months ]
    Local control and patterns of failure
  • Survival [ Time Frame: 12-24 months ]
Same as current
Not Provided
Not Provided
 
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
Radiation: Adaptive Radiation
Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
April 2015
April 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with histologically or cytologically proven newly diagnosed small cell lung cancer
  • chest-confined disease (including bulky intrathoracic disease)
  • adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
  • patients of childbearing potential must practice adequate contraception
  • Age > or = 18 years
  • Karnofsky performance status > or = 70
  • eligible for concurrent chemoradiotherapy

Exclusion Criteria:

  • patients who have undergone complete or subtotal tumour resection
  • evidence of non-small cell histology
  • prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • prior RT to the thorax or neck
  • compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
  • pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01426841
CCI Yee 25708
Yes
Not Provided
Not Provided
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Don Yee, MD, FRCPC Cross Cancer Institute, Alberta Health Services
AHS Cancer Control Alberta
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP