search
Back to results

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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
34 Gy in a single fraction
54Gy 18Gy/fr. x 3 fractions
60Gy (12 x 5 fr.s)
60Gy (7.5Gy x 8fr.)
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Català d'Oncologia - L'Hospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A. 34 Gy in a single fraction

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

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

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

Arm Description

34 Gy by single fraction Risk-adapted radiation dose.

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2013
Last Updated
August 6, 2019
Sponsor
Institut Català d'Oncologia
search

1. Study Identification

Unique Protocol Identification Number
NCT01823003
Brief Title
Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases
Acronym
sbrtlungfff
Official Title
Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Keywords
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A. 34 Gy in a single fraction
Arm Type
Experimental
Arm Description
34 Gy by single fraction Risk-adapted radiation dose.
Arm Title
B. 54Gy (18Gy/fr. x 3 fractions)
Arm Type
Experimental
Arm Description
54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose
Arm Title
C. 50Gy (12 x 5 fr.s)
Arm Type
Experimental
Arm Description
54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose
Arm Title
D. 60Gy (7.5Gy x 8fr.)
Arm Type
Experimental
Arm Description
60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose
Intervention Type
Radiation
Intervention Name(s)
34 Gy in a single fraction
Intervention Description
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
Intervention Name(s)
54Gy 18Gy/fr. x 3 fractions
Intervention Description
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
Intervention Name(s)
60Gy (12 x 5 fr.s)
Intervention Description
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
Intervention Name(s)
60Gy (7.5Gy x 8fr.)
Intervention Description
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.
Primary Outcome Measure Information:
Title
probability of not suffering a grade 3 or higher toxicity
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Tumour response
Description
To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.
Time Frame
One year
Title
Incidence of acute and late toxicities
Description
To evaluate the frequency of acute and late toxicities.
Time Frame
One year
Title
Overall survival
Description
To evaluate the impact of local therapy on overall survival.
Time Frame
One year
Title
Disease-free survival
Description
To evaluate the impact of local therapy on disease-free survival.
Time Frame
One year
Title
Effect in brochopulmonary (COPD) disease.
Description
To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.
Time Frame
One year
Title
Feasibility
Description
To evaluate the feasibility of this technique in terms of technical complications.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Navarro-Martin, md
Organizational Affiliation
Institut Català d'Oncologia L'Hospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs