Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

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

Rekrutierend

NCT-Nummer:
NCT04946357

Studienbeginn:
Juni 2021

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Klaus Herfarth, Prof. Dr.
Kontakt:
Phone: 06221 56 34093
E-Mail: studienkoordination.RAD@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Heidelberg, Department of RadioOncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Klaus Herfarth
Phone: 062215634093
E-Mail: studienkoordination.RAD@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Oncologic complete local excision (wide resection) combined with radiotherapy forms the

standard treatment for patients with soft tissue sarcoma. Especially patients with G2/G3

sarcomas profit from the combination of radiotherapy and surgery. Well-differentiated

sarcomas (G1) after total resection (R0) receive no subsequent treatment besides surgery. The

sequence of surgery and radiation therapy is widely discussed by the radiation oncologists

and surgeons. The main advantages of neoadjuvant (pre-operative) radiotherapy are the smaller

treatment target volumes and reduced prescribed radiation doses of 50 Gy vs. 66 Gy

(postoperative) in 2 Gy single doses. Thus, due to these reductions in volumes and dose,

neoadjuvant radiotherapy is associated with a lower rate of radiotherapy-associated edema and

fibrosis. However, a randomized phase III study showed an increased rate of wound healing

complications in patients with neoadjuvant radiotherapy compared to adjuvant (post-operative)

radiotherapy (35% vs. 17%). For this reason, adjuvant radiotherapy in is currently preferred

in cases with good operability.

Particle therapy bears the chance to utilize the advantages of preoperative radiotherapy

without compromising wound healing. The advantages of tumor treatment by ion therapy are

based on their special biological and physical features. Protons and carbons ion lead to an

improved dose distribution compared to photons which allows an improved sparing of the

neighboring risk organs and at the same time an escalation of the dose prescribed to the

tumor. Carbon ions are furthermore superior to protons by biological advantages based on

their enhanced biological effectivity. In general, heavy ions are considered as a good

treatment option for tumors of low radiosensitivity as sarcomas. Superior survival and

decreased toxicity rates are expected from the use of protons and carbon ions.

This randomized prospective open-label phase 2 trial testes the safety and feasibility of a

hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate

of wound healing disorders from beginning of radiotherapy to maximum 120 days after the

planned tumor resection or discontinuation of treatment due to any reason. The treatment is

of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most

patients and thus enhance quality of life. The treatment regimen furthermore promises a

reduced rate of late side effects and significant optimization of the current treatment

standards. A phase II trial is mandatory not only for obtaining the safety and feasibility

data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of

soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully

completed based on previous experiences in trials for seldom tumor entities.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed soft-tissue sarcoma of the extremities with an indication for

perioperative radiation treatment

- Resectable or marginally resectable

- Karnofsky index of ≥ 70%

- Age ≥ 18 years

- Carried out patient education and written consent

- Patient is capable to give informed consent

Exclusion Criteria:

- Stage IV (distant metastases)

- Lymph node metastasis

- Metal implants that influence treatment planning with ions

- Previous radiotherapy in the treatment area

- Desmoid tumors

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

of the study.

- Active medical implants for which no ion beam irradiation permit exists at the time of

treatment (e.g., cardiac pacemaker, defibrillator)

Studien-Rationale

Primary outcome:

1. Proportion of therapies without wound healing disorders and/or discontinuation (Time Frame - from the beginning of radiotherapy (day1) until a maximum of 120 days after the resection):
Proportion of therapies without wound healing disorders and / or discontinuation in each study arm.

Secondary outcome:

1. LC: Local control (Time Frame - from start of radiotherapy to local onset to local tumor progression up to 5 years):
LC: Local control determined from local onset to local tumor progression

2. LPFS: locally progression-free survival determined from onset of therapy to local tumor progression (Time Frame - from start of radiotherapy to onset of therapy of local tumor progression up to 5 years):
LPFS: locally progression-free survival determined from onset of therapy to local tumor progression

3. DFS: Disease-free survival (Time Frame - from start of radiotherapy to onset of therapy until local and / or distant tumor progression up to 5 years):
DFS: Disease-free survival determined from onset of therapy until local and / or distant tumor progression

4. OS: Overall survival (Time Frame - from start of radiotherapy until death or censorship up to 5 years):
OS: Overall survival until death or censorship

Studien-Arme

Experimental: Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Experimental: Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))

Geprüfte Regime

Protons:
proton irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions
carbon ions:
carbon ion irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions

Quelle: ClinicalTrials.gov

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