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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
Tan Tock Seng Hospital
Information provided by:
National University Hospital, Singapore Identifier:
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

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

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00938418

Contact: Ivan Tham, MD 6567724870
Contact: Jay Lu, MD 6567724870

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 Identifier: NCT00938418     History of Changes
Other Study ID Numbers: B/09/108
Study First Received: July 10, 2009
Last Updated: July 10, 2009

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on August 23, 2017