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

NCT ID: NCT00938418

Last Updated: 2009-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stage III Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dose escalated, accelerated, hypofractionated radiotherapy

Intensity modulated radiotherapy with concurrent chemotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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National University Health System

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Ivan Tham, MD

Role: CONTACT

6567724870

Jay Lu, MD

Role: CONTACT

6567724870

Facility Contacts

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Jay Lu, MD

Role: primary

6567724870

Cheng Nang Leong, MD

Role: primary

6563571070

Other Identifiers

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B/09/108

Identifier Type: -

Identifier Source: org_study_id

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