Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01426841
• Other study ID #: CCI Yee 25708
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 15, 2011
• Last updated: October 1, 2014
• Start date: August 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Adaptive Radiation
Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach	Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray	12-24 months	No
Secondary	Local control and patterns of failure	Local control and patterns of failure	12-24 months	No
Secondary	Survival		12-24 months	No