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

Phase 2

• Conditions: Non-Small Cell Lung Carcinoma
• Interventions: Radiation: Radiotherapy (Fractionated stereotactic body radiation)

• Registration Number: NCT02224547
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy (Fractionated stereotactic body radiation)	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 17 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UZ Brussel Radiotherapie dienst; 🇧🇪 Jette, Brussels, Belgium