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

Sponsor

AZ-VUB (Other)

Overall Status

Unknown status

CT.gov ID

NCT00727350

Collaborator

(none)

Enrollment

Location

Arm

69.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Carcinoma	Radiation: Fractionated stereotactic body radiation therapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2007

Anticipated Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.	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.

Arm

Intervention/Treatment

Experimental: 1

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.

Radiation: Fractionated stereotactic body radiation therapy

Outcome Measures

Primary Outcome Measures

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.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
Maximal tumor diameter of 6 cm
Only T3 lesions based upon thoracic wall involvement
Informed consent is required
Life expectancy of at least 6 months
Age > 18 y.
Karnofsky score ≥ 70 or ECOG score ≤ 1
Inoperable patients or patients refusing surgery
Patients with measurable lesion (according to RECIST criteria)

Exclusion Criteria:

Diagnosis of small cell lung cancer
Lymph node involvement
Prior radiotherapy or chemotherapy for lung cancer
Pregnant or lactating women
Known allergy for CT contrast
No FDG-PET
Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
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.