Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907569

Enrollment

Registered

2009-05-22

Start date

2009-06-30

Completion date

2011-04-30

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasm, Small Cell Carcinoma

Keywords

Small cell lung cancer, radiotherapy dose escalation

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.

Interventions

RADIATIONHypofractionated Chest Radiotherapy

Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
2-year overall survival	2011

Secondary

Measure	Time frame
Quality of life	2011
Patterns of Failure	2011

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026