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Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT00907569
Collaborator
Cross Cancer Institute (Other)
2
Enrollment
1
Location
22
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Hypofractionated Chest Radiotherapy
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Outcome Measures

Primary Outcome Measures

  1. 2-year overall survival [2011]

Secondary Outcome Measures

  1. Quality of life [2011]

  2. Patterns of Failure [2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

Sponsors and Collaborators

  • AHS Cancer Control Alberta
  • Cross Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00907569
Other Study ID Numbers:
  • 24762
First Posted:
May 22, 2009
Last Update Posted:
Feb 22, 2016
Last Verified:
Sep 1, 2011
Keywords provided by AHS Cancer Control Alberta
Small cell lung cancer
radiotherapy dose escalation
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell

Study Results

No Results Posted as of Feb 22, 2016