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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
Information provided by (Responsible Party):
AHS Cancer Control Alberta Identifier:
First received: April 15, 2011
Last updated: October 1, 2014
Last verified: October 2014
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: 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

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

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
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Please refer to this study by its identifier: NCT01426841

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

Responsible Party: AHS Cancer Control Alberta Identifier: NCT01426841     History of Changes
Other Study ID Numbers: CCI Yee 25708
Study First Received: April 15, 2011
Last Updated: October 1, 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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on April 28, 2017