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

NCT ID: NCT01823003

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2020-07-31

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A. 34 Gy in a single fraction

34 Gy by single fraction Risk-adapted radiation dose.

Group Type: EXPERIMENTAL

34 Gy in a single fraction

Intervention Type: RADIATION

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.

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

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

Group Type: EXPERIMENTAL

54Gy 18Gy/fr. x 3 fractions

Intervention Type: RADIATION

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.

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

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

Group Type: EXPERIMENTAL

60Gy (12 x 5 fr.s)

Intervention Type: RADIATION

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.

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

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

Group Type: EXPERIMENTAL

60Gy (7.5Gy x 8fr.)

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: RADIATION

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.

Intervention Type: RADIATION

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arturo Navarro-Martin, md

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncologia L'Hospitalet

Locations

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Other Identifiers

sbrt_lung_fff2012

Identifier Type: -

Identifier Source: org_study_id