Status:

UNKNOWN

Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Lead Sponsor:

AZ-VUB

Conditions:

Non Small Cell Lung Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tum...

Eligibility Criteria

Inclusion

  • Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
  • Maximal tumor diameter of 6 cm
  • Only T3 lesions based upon thoracic wall involvement
  • Informed consent is required
  • Life expectancy of at least 6 months
  • Age \> 18 y.
  • Karnofsky score ≥ 70 or ECOG score ≤ 1
  • Inoperable patients or patients refusing surgery
  • Patients with measurable lesion (according to RECIST criteria)

Exclusion

  • Diagnosis of small cell lung cancer
  • Lymph node involvement
  • Prior radiotherapy or chemotherapy for lung cancer
  • Pregnant or lactating women
  • Known allergy for CT contrast
  • No FDG-PET
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT00727350

Start Date

March 1 2007

End Date

December 1 2012

Last Update

August 4 2008

Active Locations (1)

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UZ Brussel

Jette, Brussels Capital, Belgium, 1090