Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer

Stage III Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00938418
• Other study ID #: B/09/108
• Status: Recruiting
• Phase: Phase 2
• First received: July 10, 2009
• Last updated: July 10, 2009
• Start date: July 2009

Study information

• Verified date: July 2009
• Source: National University Hospital, Singapore
• Contact: Ivan Tham, MD
• Phone: 6567724870
• Email: ivan_wk_tham[@]nuh.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-Small Cell Lung Cancer

Intervention

Radiation:
• Dose escalated, accelerated, hypofractionated radiotherapy
Intensity modulated radiotherapy with concurrent chemotherapy

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years	No
Secondary	Response rate, locoregional control, disease free survival, toxicity		2 years	Yes