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NCT Number: NCT00907569

Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated Chest Radiotherapy

Radiation

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

Primary outcomes

  1. 2-year overall survival

    Time frame: 2011

Secondary outcomes

  1. Quality of life

    Time frame: 2011

  2. Patterns of Failure

    Time frame: 2011

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 22, 2009
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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