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Carcinoma, Non-Small-Cell LungPhase 2sbrtlungfffNCT01823003

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

A Phase 2 study testing 34 Gy in a single fraction, 54Gy 18Gy/fr. x 3 fractions and 60Gy (12 x 5 fr.s) in people with Carcinoma, Non-Small-Cell Lung and Neoplasm Metastasis, run by Institut Català d'Oncologia at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
34 Gy in a single fraction, 54Gy 18Gy/fr. x 3 fractions and 60Gy (12 x 5 fr.s)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteSpain
Study dates
Jun 2012to Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
34 Gy in a single fraction, 54Gy 18Gy/fr. x 3 fractions, 60Gy (12 x 5 fr.s), 60Gy (7.5Gy x 8fr.)
Keywords
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Radiosurgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 34 Gy in a single fractionRadiation

    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 fractionsRadiation

    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)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.

  • 60Gy (7.5Gy x 8fr.)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.

Study groups in NCT01823003
Study groupRoleWhat they receive
A. 34 Gy in a single fractionExperimental34 Gy by single fraction Risk-adapted radiation dose.
Receives: Radiation: 34 Gy in a single fraction
B. 54Gy (18Gy/fr. x 3 fractions)Experimental54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose
Receives: Radiation: 54Gy 18Gy/fr. x 3 fractions
C. 50Gy (12 x 5 fr.s)Experimental54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose
Receives: Radiation: 60Gy (12 x 5 fr.s)
D. 60Gy (7.5Gy x 8fr.)Experimental60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose
Receives: Radiation: 60Gy (7.5Gy x 8fr.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one year

Secondary outcomes (6)

  1. Tumour response

    To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.

    Measured: One year

  2. Incidence of acute and late toxicities

    To evaluate the frequency of acute and late toxicities.

    Measured: One year

  3. Overall survival

    To evaluate the impact of local therapy on overall survival.

    Measured: One year

  4. Disease-free survival

    To evaluate the impact of local therapy on disease-free survival.

    Measured: One year

  5. Effect in brochopulmonary (COPD) disease.

    To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.

    Measured: One year

  6. Feasibility

    To evaluate the feasibility of this technique in terms of technical complications.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2019 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01823003
Sponsor's protocol ID
sbrt_lung_fff2012
Acronym
sbrtlungfff
Status last verified
Aug 2019
First submitted
25 Mar 2013
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 34 Gy in a single fraction, 54Gy 18Gy/fr. x 3 fractions and 60Gy (12 x 5 fr.s) in people with Carcinoma, Non-Small-Cell Lung and Neoplasm Metastasis, run by Institut Català d'Oncologia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

probability of not suffering a grade 3 or higher toxicity (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01823003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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