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Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Thank you

Trial Information

Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

probability of not suffering a grade 3 or higher toxicity

Outcome Description:

Patients will be follow-up during one year. If patient suffered any toxicity grade 3 or higher during this period it will be classified as having toxicity. Otherwise patient will be classified as not having toxicity.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Arturo Navarro-Martin, md

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut CatalĂ  d'Oncologia - L'Hospitalet


Spain: Ethics Committee

Study ID:




Start Date:

June 2012

Completion Date:

June 2018

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis
  • Radiosurgery
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis
  • Neoplasms, Second Primary