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

Primary Purpose

Stage III Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Dose escalated, accelerated, hypofractionated radiotherapy
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Non-Small Cell Lung Cancer

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University HospitalRecruiting
  • National University HospitalRecruiting
  • Tan Tock Seng HospitalRecruiting

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Response rate, locoregional control, disease free survival, toxicity

Full Information

First Posted
July 10, 2009
Last Updated
July 10, 2009
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00938418
Brief Title
Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer
Official Title
Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Dose escalated, accelerated, hypofractionated radiotherapy
Intervention Description
Intensity modulated radiotherapy with concurrent chemotherapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rate, locoregional control, disease free survival, toxicity
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Tham, MD
Phone
6567724870
Email
ivan_wk_tham@nuh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Lu, MD
Phone
6567724870
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Lu, MD
Phone
6567724870
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Nang Leong, MD
Phone
6563571070
First Name & Middle Initial & Last Name & Degree
Cheng Nang Leong, MD

12. IPD Sharing Statement

Learn more about this trial

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

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