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

Non-Small Cell Lung Carcinoma Clinical Trial

Official title:

Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02224547
• Other study ID #: Lung Vero SBRT
• Status: Recruiting
• Phase: Phase 2
• First received: May 27, 2014
• Last updated: September 8, 2014
• Start date: January 2013

Study information

• Verified date: September 2014
• Source: Universitair Ziekenhuis Brussel
• Contact: Christine Collen, MD
• Phone: +324763438
• Email: christine.collen[@]uzbrussel.be
• Is FDA regulated: No
• Health authority: Belgium: UZ Brussel Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Carcinoma

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel Radiotherapie dienst	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Quality of life	baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT	No
Primary	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)	From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity	Yes
Secondary	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.	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.	No