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Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

This study is currently recruiting participants.
Verified December 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01426841
First received: April 15, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
 Radiation: Adaptive Radiation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Project of Adaptive Thoracic Radiotherapy for 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:
  • Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray


Secondary Outcome Measures:
  • Local control and patterns of failure [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Local control and patterns of failure

  • Survival [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Adaptive Radiation
    Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426841

Contacts
Contact: Don Yee, MD FRCPC 780-432-8783 don.yee@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Don Yee, MC FRCPC            
Sub-Investigator: Charles Butts, MD FRCPC            
Sub-Investigator: Quincy Chu, MD FRCPC            
Sub-Investigator: Michael Smylie, MD FRCPC            
Sub-Investigator: Dave Fenton, MC FRCPC            
Sub-Investigator: Anil Joy, MD FRCPC            
Sub-Investigator: Randeep Sangha, MC FRCPC            
Sponsors and Collaborators
Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01426841     History of Changes
Other Study ID Numbers: CCI Yee 25708
Study First Received: April 15, 2011
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Small cell lung cancer
Adaptive radiotherapy
Thoracic 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 June 18, 2013