NCT00938418

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

July 10, 2009

Last Update Submit

July 10, 2009

Conditions

Stage III Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2 years

Secondary Outcomes (1)

  • Response rate, locoregional control, disease free survival, toxicity

    2 years

Interventions

Dose escalated, accelerated, hypofractionated radiotherapyRADIATION

Intensity modulated radiotherapy with concurrent chemotherapy

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ivan Tham, MD

CONTACT

6567724870ivan_wk_tham@nuh.com.sg

Jay Lu, MD

CONTACT

6567724870

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

SG(3)