Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Small Cell Carcinoma; Lung Neoplasm

• Registration Number: NCT00907569
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

Detailed Description

The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Study Start: 2009-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-09
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• limited stage small cell lung cancer
• adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
• signed study consent
• age at least 18 years
• Karnofsky performance status as least 70%
• eligible to receive standard concurrent small cell cancer chemotherapy

Exclusion Criteria

• extensive stage disease
• mixed non small cell and small cell histology
• inadequate pulmonary function tests
• not eligible for concurrent chemotherapy
• subtotal or total tumor resection
• previous chest/neck radiotherapy
• prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
• pregnant
• prior chemotherapy for another malignancy
• patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
2-year overall survival	2011

Secondary Outcome Measures

Name	Time	Method
Patterns of Failure	2011
Quality of life	2011

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada