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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— sbrtlungfff  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01823003
• Other study ID #: sbrt_lung_fff2012
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: July 2020

Study information

• Verified date: August 2019
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Radiation:
• 34 Gy in a single fraction
34 Gy in a single fraction in case of Distance to chest wall > 1 cm, tumour size < 2 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
• 54Gy 18Gy/fr. x 3 fractions
54Gy administered in 3 fractions of 18Gy in case of distance to chest wall > 1 cm, tumour size between 2 and 5 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
• 60Gy (12 x 5 fr.s)
50Gy administered in 5 fractions of 12 Gy for Peripheral Nodes in case of distance to chest wall < 1 cm, tumour size < 5 cm and distance to main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
• 60Gy (7.5Gy x 8fr.)
60 Gy administered in 8 fractions of 7.5 Gy for mediastinal nodes in case of tumour size < 5 cm and distance to the main bronchus < 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probability of not suffering a grade 3 or higher toxicity	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.	one year
Secondary	Tumour response	To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.	One year
Secondary	Incidence of acute and late toxicities	To evaluate the frequency of acute and late toxicities.	One year
Secondary	Overall survival	To evaluate the impact of local therapy on overall survival.	One year
Secondary	Disease-free survival	To evaluate the impact of local therapy on disease-free survival.	One year
Secondary	Effect in brochopulmonary (COPD) disease.	To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.	One year
Secondary	Feasibility	To evaluate the feasibility of this technique in terms of technical complications.	One year