Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

NCT ID: NCT00907569

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-04-30

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.

Conditions

Lung Neoplasm; Small Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Hypofractionated Chest Radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

24762

Identifier Type: -

Identifier Source: org_study_id