Clinical trial NCT01823003: Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases
Official title: Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Keywords: Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Radiosurgery
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: probability of not suffering a grade 3 or higher toxicity
timeFrame: one year
Secondary outcomes:
measure: Tumour response
timeFrame: One year
measure: Incidence of acute and late toxicities
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Disease-free survival
timeFrame: One year
measure: Effect in brochopulmonary (COPD) disease.
timeFrame: One year
measure: Feasibility
timeFrame: One year
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia L'Hospitalet
name: Arturo Navarro-Martin, md
role: PRINCIPAL_INVESTIGATOR
References: