Clinical trial NCT02224547: Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System
Official title: Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Carcinoma
Keywords: non-small cell lung cancer
lung carcinoma
NSCLC
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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, 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.

Primary outcomes:
measure: Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
timeFrame: From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
Secondary outcomes:
measure: Time to local progression
timeFrame: 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.
Other outcomes:
measure: Quality of life
timeFrame: baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT
Locations:
city: Jette
country: Belgium
facility: UZ Brussel Radiotherapie dienst
state: Brussels
Study officials:
affiliation: UZ Brussel Radiotherapie dienst
name: Christine Collen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.