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

Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00938418
Enrollment
43
Registered
2009-07-13
Start date
2009-07-31
Completion date
Unknown
Last updated
2009-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Non-Small Cell Lung Cancer

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.

Interventions

RADIATIONDose escalated, accelerated, hypofractionated radiotherapy

Intensity modulated radiotherapy with concurrent chemotherapy

Sponsors

Tan Tock Seng Hospital
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Overall survival2 years

Secondary

MeasureTime frame
Response rate, locoregional control, disease free survival, toxicity2 years

Countries

Singapore

Contacts

Primary ContactIvan Tham, MD
ivan_wk_tham@nuh.com.sg6567724870
Backup ContactJay Lu, MD
6567724870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026