Overview

This trial is active, not recruiting.

Condition small cell lung cancer
Treatment adaptive radiation
Phase phase 1
Sponsor AHS Cancer Control Alberta
Start date August 2011
End date April 2015
Trial size 10 participants
Trial identifier NCT01426841, CCI Yee 25708

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
time frame: 12-24 months

Secondary Outcomes

Measure
Local control and patterns of failure
time frame: 12-24 months
Survival
time frame: 12-24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Principal investigator Don Yee, MD, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.