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


Phase 2
21 Years
70 Years
Open (Enrolling)
Both
Stage III Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Singapore: Health Sciences Authority

Study ID:

B/09/108

NCT ID:

NCT00938418

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Stage III Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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