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

August 6, 2019 updated by: Institut Català d'Oncologia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A. 34 Gy in a single fraction
34 Gy by single fraction Risk-adapted radiation dose.
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.
EXPERIMENTAL: B. 54Gy (18Gy/fr. x 3 fractions)
54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose
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.
EXPERIMENTAL: C. 50Gy (12 x 5 fr.s)
54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose
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.
EXPERIMENTAL: D. 60Gy (7.5Gy x 8fr.)
60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probability of not suffering a grade 3 or higher toxicity
Time Frame: one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour response
Time Frame: One year
To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.
One year
Incidence of acute and late toxicities
Time Frame: One year
To evaluate the frequency of acute and late toxicities.
One year
Overall survival
Time Frame: One year
To evaluate the impact of local therapy on overall survival.
One year
Disease-free survival
Time Frame: One year
To evaluate the impact of local therapy on disease-free survival.
One year
Effect in brochopulmonary (COPD) disease.
Time Frame: One year
To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.
One year
Feasibility
Time Frame: One year
To evaluate the feasibility of this technique in terms of technical complications.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Català d'Oncologia

Investigators

  • Principal Investigator: Arturo Navarro-Martin, md, Institut Catala d'Oncologia L'Hospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sbrt_lung_fff2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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