Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System

Universitair Ziekenhuis Brussel58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Carcinoma

Interventions

Radiotherapy (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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Toxicity of grade 3+ as assessed by NCI CTCAE v4.0

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)

Time frame: From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity

Secondary Outcomes

Time to local progression

Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.

Time frame: 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.