Non Small Cell Lung Carcinoma
Conditions
Keywords
NSCLC, Novalis, Stereotactic, SBRT, T1, T2 or T3NO NSCLC
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 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)
Interventions
RADIATIONFractionated stereotactic body radiation therapy
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.
Sponsors
AZ-VUB
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT). | Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly. |
Secondary
| Measure | Time frame |
|---|---|
| Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples. | Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly. |
Countries
Belgium
Contacts
Primary ContactSamuel Bral, MD
Outcome results
None listed