Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00727350
• Other study ID #: SBRT-NSCLC
• Status: Recruiting
• Phase: Phase 2
• First received: July 31, 2008
• Last updated: August 1, 2008
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: August 2008
• Source: AZ-VUB
• Contact: Samuel Bral, MD
• Phone: 00324763435
• Email: samuel.bral[@]uzbrussel.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

4. Informed consent is required

5. Life expectancy of at least 6 months

6. Age > 18 y.

7. Karnofsky score = 70 or ECOG score = 1

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 or chemotherapy for lung cancer

4. Pregnant or lactating women

5. Known allergy for CT contrast

6. No FDG-PET

7. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

8. 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

Allocation: Non-Randomized, 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:
• Fractionated stereotactic body radiation therapy
For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
AZ-VUB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT).		Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.	Yes
Secondary	Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples.		Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.	No