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

July 10, 2009 updated by: National University Hospital, Singapore

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • B/09/108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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