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

AZ-VUB

Status and phase: Unknown; Phase 2

Conditions: Non Small Cell Lung Carcinoma

Treatments: Radiation: Fractionated stereotactic body radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00727350

SBRT-NSCLC

Details and patient eligibility

About

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)

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Radiation: Fractionated stereotactic body radiation therapy