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Trial Title:
Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
NCT ID:
NCT00727350
Condition:
Non Small Cell Lung Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
Novalis
Stereotactic
SBRT
T1, T2 or T3NO NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Fractionated stereotactic body radiation therapy
Description:
For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions
located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks. For
both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2
separate fractions. There should be a maximum of 2 fractions per week.
Arm group label:
1
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ Brussel
Address:
City:
Jette
Zip:
1090
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Samuel Bral, MD
Phone:
003224763435
Email:
samuel.bral@uzbrussel.be
Investigator:
Last name:
Samuel Bral, MD
Email:
Principal Investigator
Start date:
March 2007
Completion date:
December 2012
Lead sponsor:
Agency:
AZ-VUB
Agency class:
Other
Source:
AZ-VUB
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00727350
