Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

National University Hospital, Singapore2 sites in 1 country43 target enrollmentJuly 2009

ConditionsStage III Non-Small Cell Lung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Stage III Non-Small Cell Lung Cancer
Sponsor: National University Hospital, Singapore
Enrollment: 43
Locations: 2
Primary Endpoint: Overall survival
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.

This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.

This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

July 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National University Hospital, Singapore

Eligibility Criteria

Inclusion Criteria

•Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.

Exclusion Criteria

•Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
•Greater than minimal, exudative, or cytologically positive pleural effusions
•≥ 10% weight loss within the past month
•Prior invasive malignancy (with exceptions)
•Prior radiotherapy to the region of the study cancer
•Significant co-morbidities
•Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
•Known allergic reactions to components of planned chemotherapy regimen