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Clinical Trials/NCT01426841
NCT01426841
Unknown
Phase 1

Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

AHS Cancer Control Alberta1 site in 1 country10 target enrollmentAugust 2011
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ConditionsSmall Cell Lung Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Small Cell Lung Cancer
Sponsor
AHS Cancer Control Alberta
Enrollment
10
Locations
1
Primary Endpoint
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
April 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Survival(12-24 months)
  • Local control and patterns of failure(12-24 months)

Study Sites (1)

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