Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases (sbrtlungfff)

Institut Català d'Oncologia

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Treatments: Radiation: 60Gy (7.5Gy x 8fr.); Radiation: 54Gy 18Gy/fr. x 3 fractions; Radiation: 34 Gy in a single fraction; Radiation: 60Gy (12 x 5 fr.s)

Study type: Interventional

Funder types: Other

Identifiers

NCT01823003

sbrt_lung_fff2012

Details and patient eligibility

About

This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the impact of local therapy on overall and disease-free survival.

Full description

The intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronchus.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX> 4).
• Tumour size < 5 cm in diameter prior to treatment.
• Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
• Life expectancy of >12 months.
• Criterion for medical inoperability include:

Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age > 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg.

• Age > 18 years.
• KPS > 70.
• Barthel score >40
• Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
• If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

• Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan.
• More than two lesions per lobe.
• Active infections requiring systemic antibiotics.
• Age <18 years old.
• KPs < 70.
• Barthel Total Score < 40.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 4 patient groups

A. 34 Gy in a single fraction

Experimental group

Description:

34 Gy by single fraction Risk-adapted radiation dose.

Treatment:

Radiation: 34 Gy in a single fraction

B. 54Gy (18Gy/fr. x 3 fractions)

Experimental group

Description:

54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose

Treatment:

Radiation: 54Gy 18Gy/fr. x 3 fractions

C. 50Gy (12 x 5 fr.s)

Experimental group

Description:

54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose

Treatment:

Radiation: 60Gy (12 x 5 fr.s)

D. 60Gy (7.5Gy x 8fr.)

Experimental group

Description:

60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose

Treatment:

Radiation: 60Gy (7.5Gy x 8fr.)