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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938418
First Posted: July 13, 2009
Last Update Posted: July 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tan Tock Seng Hospital
Information provided by:
National University Hospital, Singapore
  Purpose

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.


Condition Intervention Phase
Stage III Non-Small Cell Lung Cancer Radiation: Dose escalated, accelerated, hypofractionated radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Response rate, locoregional control, disease free survival, toxicity [ Time Frame: 2 years ]

Estimated Enrollment: 43
Study Start Date: July 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Dose escalated, accelerated, hypofractionated radiotherapy
    Intensity modulated radiotherapy with concurrent chemotherapy
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938418


Contacts
Contact: Ivan Tham, MD 6567724870 ivan_wk_tham@nuh.com.sg
Contact: Jay Lu, MD 6567724870

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Jay Lu, MD    6567724870      
Tan Tock Seng Hospital Recruiting
Singapore, Singapore
Contact: Cheng Nang Leong, MD    6563571070      
Principal Investigator: Cheng Nang Leong, MD         
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
  More Information

Responsible Party: Dr Ivan Tham, National University Health System
ClinicalTrials.gov Identifier: NCT00938418     History of Changes
Other Study ID Numbers: B/09/108
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: July 13, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms