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Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
Conditions
Non Small Cell Lung Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
NSCLC, Novalis, Stereotactic, SBRT, T1, T2 or T3NO NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fractionated stereotactic body radiation therapy
Type: Radiation
Overall Status
Recruiting
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 tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
2. Maximal tumor diameter of 6 cm
3. Only T3 lesions based upon thoracic wall involvement
4. Informed consent is required
5. Life expectancy of at least 6 months
6. Age > 18 y.
7. Karnofsky score ≥ 70 or ECOG score ≤ 1
8. Inoperable patients or patients refusing surgery
9. Patients with measurable lesion (according to RECIST criteria)
Exclusion Criteria:
1. Diagnosis of small cell lung cancer
2. Lymph node involvement
3. Prior radiotherapy or chemotherapy for lung cancer
4. Pregnant or lactating women
5. Known allergy for CT contrast
6. No FDG-PET
7. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
8. 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.
1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
2. Maximal tumor diameter of 6 cm
3. Only T3 lesions based upon thoracic wall involvement
4. Informed consent is required
5. Life expectancy of at least 6 months
6. Age > 18 y.
7. Karnofsky score ≥ 70 or ECOG score ≤ 1
8. Inoperable patients or patients refusing surgery
9. Patients with measurable lesion (according to RECIST criteria)
Exclusion Criteria:
1. Diagnosis of small cell lung cancer
2. Lymph node involvement
3. Prior radiotherapy or chemotherapy for lung cancer
4. Pregnant or lactating women
5. Known allergy for CT contrast
6. No FDG-PET
7. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
8. 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.
Location
UZ Brussel
Jette, Brussels, Belgium
Status: Recruiting
Contact: Samuel Bral, MD - 003224763435 - samuel.bral@uzbrussel.be
Start Date
March 2007
Completion Date
December 2012
Sponsors
AZ-VUB
Source
AZ-VUB
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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