Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion

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

Rekrutierend

NCT-Nummer:
NCT04219202

Studienbeginn:
Mai 2019

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Juergen Debus, Prof.
Kontakt:
Phone: +496221
Phone (ext.): 8201
E-Mail: juergen.debus@med.uni-heidelberg.de» Kontaktdaten anzeigen

Katharina Seidensaal, MD
Kontakt:
Phone: +496221
Phone (ext.): 8201
E-Mail: katharina.seidensaal@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Uhl, PD
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: Matthias.uhl@med.uni-heidelberg.de

Adriane Hommertgen
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the

special physical properties of particles (protons and C12 carbon ions), in particular the

steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine,

kidneys, liver etc. during the process of applying radiotherapy is possible.

The primary study objective is to demonstrate the safety and conduct of study treatment and

the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for

any reason. Further target parameter is the proportion of applied therapies without the

occurance of degree 3-5 NCI-CTC-AE(s).

The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients

receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.

Secondary study objectives are local control (LC), local progression-free survival from the

start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of

life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30

questionnaire.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or

marginally resectable

- Karnofsky index of ≥ 70%

- Age from 18 years

- Completed patient information and written consent

- ability to give consent

Exclusion Criteria:

- Stage IV (distant metastases)

- Lymphogenic metastasis

- Metal implants at the level of the sarcoma, which influence the treatment planning

- Previous radiation therapy in the treatment area

- Desmoid tumors, peritoneal sarcomatosis, GIST

- Simultaneous participation in another clinical study that could influence the results

of the respective study

- Active medical implants for which there is no license for ion irradiation at the time

of treatment (e.g. pacemaker, defibrillator)

- Pregnant women

Studien-Rationale

Primary outcome:

1. Incidence of grad 3-5 NCI-CTC-AE toxicities (Time Frame - within 12 month after radiation treatment):
Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason

Secondary outcome:

1. local Tumor control (Time Frame - within 12 month after radiation treatment):
Number of patients without new arising Tumors at the treated Tumor site

2. local Progression free survival (Time Frame - within 12 month after radiation treatment):
Number of patients without local Progression at the treated tumor site

3. disease free survival (Time Frame - within 12 month after radiation treatment):
Number of Patients without relapse of treated disease

4. Overall survival (Time Frame - within 12 month after radiation treatment):
Assesment of alive patients

5. Quality of live (Time Frame - within 12 month after radiation treatment):
Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6

Studien-Arme

Active Comparator: Proton Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
Experimental: Carbon Ion Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment

Geprüfte Regime

Proton radiation:
Therapeutic radiation Treatment with Protons
Carbon Ion radiation:
Therapeutic radiation Treatment with Carbon Ions

Quelle: ClinicalTrials.gov

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