NCT00938418UnknownPhase 2

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 enrollmentStarted: July 1, 2009Last updated: July 13, 2009

Conditions

Trial Snapshot

Phase: Phase 2
Sponsor: National University Hospital, Singapore
Enrollment: 43
Locations: 2
Primary Endpoint: Overall survival

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study 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.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 21 Years to 70 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Outcomes

Primary Outcomes

Overall survival

Time Frame: 2 years

Secondary Outcomes

Response rate, locoregional control, disease free survival, toxicity(2 years)

Investigators

Sponsor

National University Hospital, Singapore

Sponsor Class

Other

Study Sites (2)

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