Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT04889742

Studienbeginn:
Mai 2024

Letztes Update:
26.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neuroendocrine Tumors, Anus Neoplasms, Pancreatic Neoplasms, Fever, Recurrence, Hyperthermia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Studienleiter

Sebastian Zschaeck, MD
Principal Investigator
Charité

Kontakt

Sebastian Zschaeck, MD
Kontakt:
Phone: +4930450650764
E-Mail: sebastian.zschaeck@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinik für Radioonkologie und Strahlentherapie
13353 Berlin
(Berlin)
Germany» Google-Maps
Ansprechpartner:
Sebastian Zschaeck, M.D.» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

patients that present a relapse within the previously irradiated volume can be included in

this trial. These patients will receive re-irradiation according to clinical guidelines and

hyperthermia as study intervention. According to tumor location hyperthermia can either be

performed by microwave or by capacitive devices.

The primary endpoint of this study is non-inferiority of re-irradiation compared to the

initial course of radiotherapy (calculated as time to local failure).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2

(calculated with alpha/beta value of 9)

- local/ regional / or oligometastatic tumor recurrence. Maximum number of three

macroscopic tumor lesions with at least one of them receiving prior radiotherapy

- macroscopic tumor recurrence

- side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine,

cervical lymphnodes)

- planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value

of 9)

Exclusion Criteria:

- >3 macroscopic tumor lesion

- brain metastases

- recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic

radiotherapy)

- recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)

- contraindications for hyperthermia (serious cariovascular disease, ICD or larger

implants at the treatment site)

- psychiatric disorders that impede proper informed consent

- serious comorbidities with very limited prognosis quo ad vitam

Studien-Rationale

Primary outcome:

1. Local tumor recurrence (Time Frame - 3 years):
Local tumor recurrence of re-irradiated lesions, calculated with the Kaplan-Meier estimates. Local recurrence after hyperthermic re-irradiation will be compared to time-to recurrence after initial treatment.

Secondary outcome:

1. Overall survival (Time Frame - 3 years):
Overall survival after start of re-irradiation

2. Progression-free survival (Time Frame - 3 years):
Progression-free survival after start of re-irradiation

3. Freedom from distant metastases (Time Frame - 3 years):
Freedom from distant metastases after start of re-irradiation

4. Patient reported quality of Life (Time Frame - 3 years):
patient reported quality of life measured by the EORTC qlq-c30 questionnaire.

Geprüfte Regime

loco-regional hyperthermia:
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.

Quelle: ClinicalTrials.gov

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