NCT01426841UnknownPhase 1
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
AHS Cancer Control Alberta1 site in 1 country10 target enrollmentStarted: August 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- AHS Cancer Control Alberta
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
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)
Investigators
Study Sites (1)
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