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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 because the information has not been verified recently.
Verified July 2009 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tan Tock Seng Hospital
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00938418
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Ivan Tham, National University Health System
ClinicalTrials.gov Identifier: NCT00938418     History of Changes
Other Study ID Numbers: B/09/108
Study First Received: July 10, 2009
Last Updated: July 10, 2009
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on May 16, 2013