Non-Small Cell Lung Carcinoma
Conditions
Keywords
non-small cell lung cancer, lung carcinoma, NSCLC
Brief summary
The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
Interventions
RADIATIONRadiotherapy (Fractionated stereotactic body radiation)
Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, 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
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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, only 1 lesion 4. Informed consent is required 5. Life expectancy of at least 6 months 6. Age \>/= 18 y. 7. Karnofsky score ≥ 70 or ECOG score ≤ 2 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 to the chest and/or mediastinum 4. No chemotherapy and/or targeted treatment within 3 months before SBRT 5. Pregnant or lactating women 6. Known allergy for CT contrast 7. No FDG-PET 8. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. 9. 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 | Description |
|---|---|---|
| Toxicity of grade 3+ as assessed by NCI CTCAE v4.0 | From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity | To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to local progression | every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months. | Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT | Quality of life |
Countries
Belgium
Contacts
Primary ContactChristine Collen, MD
Backup ContactHarijati Versmessen, MD
Outcome results
None listed