Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907569
• Other study ID #: 24762
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2009
• Last updated: February 18, 2016
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasm
• Lung Neoplasms
• Small Cell Carcinoma
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Hypofractionated Chest Radiotherapy
Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival		2011	No
Secondary	Quality of life		2011	No
Secondary	Patterns of Failure		2011	No