NCT01823003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

7.5 years

First QC Date

March 25, 2013

Last Update Submit

August 6, 2019

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Keywords

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisRadiosurgery

Outcome Measures

Primary Outcomes (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.

    one year

Secondary Outcomes (6)

  • Tumour response

    One year

  • Incidence of acute and late toxicities

    One year

  • Overall survival

    One year

  • Disease-free survival

    One year

  • Effect in brochopulmonary (COPD) disease.

    One year

  • +1 more secondary outcomes

Study Arms (4)

A. 34 Gy in a single fraction

EXPERIMENTAL

34 Gy by single fraction Risk-adapted radiation dose.

Radiation: 34 Gy in a single fraction

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

EXPERIMENTAL

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

Radiation: 54Gy 18Gy/fr. x 3 fractions

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

EXPERIMENTAL

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

Radiation: 60Gy (12 x 5 fr.s)

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

EXPERIMENTAL

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

Radiation: 60Gy (7.5Gy x 8fr.)

Interventions

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.

A. 34 Gy in a single fraction
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.

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

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arturo Navarro-Martin, md

    Institut Català d'Oncologia L'Hospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 4, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

ES(1)