JOURNAL ONKOLOGIE – STUDIE

Lung_Cancer_adaptive - Ethos

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06222190

Studienbeginn:
August 2023

Letztes Update:
24.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienleiter

Martin Stuschke, MD
Study Director
Klinik für Strahlentherapie, Universitätsklinikum Essen

Kontakt

Christoph Pöttgen, MD
Kontakt:
Phone: +49 201 723
Phone (ext.): 2321
E-Mail: christoph.poettgen@uk-essen.de» Kontaktdaten anzeigen

Ina Grübel
Kontakt:
Phone: +49 201 723
Phone (ext.): 85054
E-Mail: ina.gruebel@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinik für Strahlentherapie, Universitätsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christoph Pöttgen, MD
Phone: +49 201 723
Phone (ext.): 2321
E-Mail: christoph.poettgen@uk-essen.de

Ina Gruebel
Phone: +49 201 723
Phone (ext.): 85054
E-Mail: ina.gruebel@uk-essen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

With online-adaptive radiotherapy (ART), the radiotherapy plan can be adapted to the

anatomical changes before each radiotherapy fraction. The basis for adaptation is a cone-beam

CT with the patient on the treatment table at the start of each radiotherapy fraction.

Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is

now the basic standard in radiotherapy. Here, a cone beam CT is also performed at the start

of each fraction, but this is only used to position the patient in relation to the radiation

field arrangement of the initial radiation plan approved for the series, so that predefined

landmarks match the target position in the planning CT as closely as possible. However, the

radiotherapy plan itself cannot be adapted to deformations in the body during IGRT, e.g. due

to different bowel and bladder fillings. IGRT is currently carried out on all linear

accelerators at the radiotherapy clinic. For online adaptive radiotherapy (ART), which allows

the radiotherapy plan to be adapted to the anatomical deformities of the day online on the

treatment table, the ETHOS® radiotherapy system from Varian-Siemens has been available at the

radiotherapy clinic for a year as a medical device with handling authorisation from the

district government. This therapy device enables on-line adaptive plan adjustment within

10-20 minutes.

In patients with lung carcinoma who receive radiotherapy preoperatively to reduce the size of

the tumour before surgery or alternatively curative, high-dose radiotherapy instead of

surgery, there are also deformations of the thorax from fraction to fraction. For example,

the depth of breathing during deep inspiration radiotherapy can change depending on the shape

of the day. Ventilation disturbances caused by the tumour may increase or decrease, pleural

effusions may occur or tumour shrinkage may occur. Furthermore, the strength of the various

respiratory muscles can vary from day to day, as can the intra-abdominal pressure.

Currently, ART for lung carcinomas is carried out as part of patient care in the radiotherapy

clinic at the University Hospital Essen. Patients are irradiated during repeated

breath-holding manoeuvres in deep inspiration. The pure irradiation time takes about 1.5

minutes. The breath-holding manoeuvre is practised several times before the daily

irradiation. An optical surface detection device is available for this purpose, which is used

to compare the body surface in the patient's thorax area on the treatment table with the

target surface to be achieved during radiotherapy planning, which took place days before the

current fraction. If the target surface is reproducibly achieved, a conebeam CT is taken to

determine the current tumour extent and the deformations occurring in comparison to the dose

distribution to be applied. For this purpose, the normal tissues heart, lung and tracheal

tree are automatically contoured by the Ethos therapy system in the cone-beam CT. A

specialist physician and a physicist are present at the Ethos device during this process.

These organ contours are used to determine the extent of the current target volume and the

adaptive radiotherapy plan is adjusted to the new target volume. If the current tumour extent

is not sufficiently covered by the initial radiotherapy plan planned for the series with its

planned tolerances, or if the surrounding normal tissue is exposed to too much radiation,

then the online adaptive radiotherapy plan for the current treatment is selected by the

specialist. Otherwise, the initial radiotherapy plan is used by the planning CT as for IGRT.

The aim of this study is to treat 30 patients in ART readiness on the Ethos therapy device

over 10 radiotherapy fractions. The dose distribution is always compared with the adaptive

and the initial series plan on the anatomy of the day by the specialist and medical physics

expert. The ART plan is then applied with dosimetric advantages. The aim of this study is to

prospectively analyse in how many patients safety margins around the clinical target volume

can be reduced with ART compared to IGRT. After the first 7 of the 10 fractions to be

administered in ART readiness, the dose is accumulated over these fractions. The percentage

of patients who benefit from ART will be determined prospectively. The criterion for a

relevant benefit from ART is the effective uniform dose (EUD) in the target volume with the

accumulated dose distribution across the 7 fractions. If the EUD is below 95% of the target

dose with IGRT and above 95% of the target dose with ART, then an advantage is determined

with ART. Such dose accumulations accompanying a radiotherapy series were not possible in the

past. Patients with a benefit from ART receive ART for the further fractions of the series,

while the others continue to be treated with IGRT.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with NSCLC/SCLC ≥18 years of age in stage III or IV, oligometastatic, for

whom the indication for neoadjuvant or definitive

radiotherapy/radiotherapy/chemotherapy has been established in the certified lung

tumour board.

Exclusion Criteria:

- Patients who are unable to perform a reproducible breath-hold manoeuvre on inspiration

are not included in this study.

Studien-Rationale

Primary outcome:

1. Advantage of ART over IGRT (Time Frame - 1.5 years):
In more than 50% of patients receiving definitive surgery-replacing or preoperative radiotherapy for locally advanced lung cancer, is it possible to reduce the planning margins around the clinical target volume (CTV) to compensate for movement and deformation with online-adaptive radiotherapy (ART) compared to IGRT?

Secondary outcome:

1. Determination of the percentage of patients who benefit from ART for lung cancer. (Time Frame - 1.5 years):
Exploratory analysis of factors that lead to an advantage of ART: Tumour shrinkage, variation in breath depth from day to day, localisation of the tumour in the lower lobe, previous lung disease, e.g. chronic obstructive pulmonary disease (COPD).

Geprüfte Regime

online-adaptive radiotherapy (ETHOS therapy system (Varian Medical Systems)):
A conebeam CT is taken to determine the current tumour extent and the deformations occurring in comparison to the dose distribution to be applied. Normal tissues heart, lung and tracheal tree are automatically contoured by the Ethos therapy system in that cone-beam CT. A specialist physician and a physicist are present during this process. These organ contours are used to determine the extent of the current target volume and the adaptive radiotherapy plan is adjusted to the new target volume. If the current tumour extent is not sufficiently covered by the initial radiotherapy plan planned for the series with its planned tolerances, or if the surrounding normal tissue is exposed to too much radiation, then the online adaptive radiotherapy plan for the current treatment is selected by the specialist. Otherwise, the initial radiotherapy plan is used for IGRT.

Quelle: ClinicalTrials.gov

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