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

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

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 Overview

• Status: Unknown
• Conditions: Stage III Non-Small Cell Lung Cancer
• Intervention / Treatment: Radiation: Dose escalated, accelerated, hypofractionated radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ivan Tham, MD; Phone Number: 6567724870; Email: ivan_wk_tham@nuh.com.sg
• Study Contact Backup: Name: Jay Lu, MD; Phone Number: 6567724870

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
    • Contact: Jay Lu, MD; Phone Number: 6567724870
  • Singapore, Singapore
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Cheng Nang Leong, MD; Phone Number: 6563571070
    • Principal Investigator: Cheng Nang Leong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate, locoregional control, disease free survival, toxicity	2 years

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 13, 2009
• Last Update Submitted That Met QC Criteria: July 10, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: B/09/108