Adaptive Radiotherapy in Patients With Gynecological Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06230549

Studienbeginn:
Januar 2024

Letztes Update:
09.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienlocations
(1 von 1)

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maja Guberina, PD Dr. med. (MD), specialist
Phone: +492017232321
E-Mail: maja.guberina@uk-essen.de

Ina Grübel» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the

anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy

is a further development of image-guided radiotherapy (IGRT), which is now standard in

radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each

fraction, which is used to position the patients in relation to the radiation field

arrangement of the initial radiation plan approved for the series. In contrast to ART, with

IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction

to radiation fraction, e.g. due to different rectum and bladder fillings.

In ART mode, the online adaptive treatment plan for the current treatment is then selected

and approved by the specialist online onboard in all cases in which the current target volume

for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned

for the series with its planned tolerances, or surrounding normal tissue is exposed too much.

If the ART plan does not show any clear dosimetric advantages over the reference plan,

especially if the initial plan covers the target volume of the day well, there are no dose

increases and the normal tissues are spared as intended, the initial radiation plan from the

planning CT can also be used as in IGRT. The aim of this study is to treat at least 15

patients with locally advanced gynecological carcinoma (mainly cervical carcinoma,

endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the

Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos

therapy device over an initial 10 radiation fractions. The dose distribution is always

compared with the adaptive and the initial plan for the radiation series on the anatomy of

the day by the specialist and medical physics expert. The aim of this study is to

prospectively investigate what percentage of patients benefit from ART when using standard

PTV margins and how to recognize the corresponding patients early in the series. Secondarily,

it will be investigated in what proportion of patients the risk organ burden and the safety

margins around the clinical target volume can be reduced with ART compared to IGRT and how

large this reduction can be.

The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in

order to quantify objective and subjective side effects.

Ein-/Ausschlusskriterien

Inclusion Criteria:

ECOG 0-1 confirmation by histophatology MR of the pelvis staging

Exclusion Criteria:

Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1

Studien-Rationale

Primary outcome:

1. Rectal Toxicity (Time Frame - 2 weeks to 5 years):
Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]

2. Bladder Toxicity (Time Frame - 2 weeks to 5 years):
Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]

3. Skin Toxicity (Time Frame - 2 weeks to 5 years):
Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]

4. Lymph-Edema grade (Time Frame - 2 weeks to 5 years):
Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, [score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL]

Secondary outcome:

1. Overall Survival (Time Frame - 5 years):
Overall Survival

2. Progression Free Survival (Time Frame - 5 years):
Progression Free Survival

Studien-Arme

Experimental: Interventional Arm
Adaptive Radiotherapy
Active Comparator: Standard conventional Treatment Arm, IGRT
Standard conventional Treatment Arm, IGRT

Geprüfte Regime

Adaptive Radiotherapy (Adaptive Radiation Therapy):
Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Quelle: ClinicalTrials.gov

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