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Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426841
First Posted: September 1, 2011
Last Update Posted: October 2, 2014
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.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Local control and patterns of failure [ Time Frame: 12-24 months ]
    Local control and patterns of failure

  • Survival [ Time Frame: 12-24 months ]

Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01426841


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

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01426841     History of Changes
Other Study ID Numbers: CCI Yee 25708
First Submitted: April 15, 2011
First Posted: September 1, 2011
Last Update Posted: October 2, 2014
Last Verified: October 2014

Keywords provided by AHS Cancer Control Alberta:
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