Prospective Hyperthermia Database in Cancer Patients (HT Register)

Rekrutierend

NCT-Nummer:
NCT05993910

Studienbeginn:
November 2014

Letztes Update:
15.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Hyperthermia, Fever

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Pirus Ghadjar

Collaborator:
-

Kontakt

Pirus Ghadjar, PD Dr.
Kontakt:
Phone: +4930450657055
E-Mail: pirus.ghadjar@charite.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Clinic for Radio - Oncology and Radiotherapy
13353 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Pirus Ghadjar, Prof Dr.
Phone: +4930450657055
E-Mail: pirus.ghadjar@charite.de» Ansprechpartner anzeigen

Clinic for Radio - Oncology and Radiotherapy
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Pirus Ghadjar, Prof. Dr.
Phone: +4930450657055
E-Mail: pirus.ghadjar@charite.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

A total of 1000 patients with various diseases with the indication for hyperthermia in

addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy)

will be included in this registry protocol.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Contrazeption with female patients at the capable of bearing children age

- Written agreement is present (DvH, ICH-GCP)

- Patients, who participate at the same time in a interventional study, can nevertheless

in this register study participate if this none Exclusion criterion for the

interventional study represents.

- With children must the treatment with one of the GPOH agreed Pattern take place

Exclusion Criteria:

- Exclusion criteria for the hyperthermia (such as hip prosthesis in the therapeutic

area, metal implants/marker, patients with cardiac pacemakers)

- mental disease, what the proper study participation does not allow.

Studien-Rationale

Primary outcome:

1. Effectivity (Time Frame - Through the study completion, up to 10 years):
To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival

2. Toxicity (Time Frame - Through the study completion, up to 10 years):
Toxicity assessment based on Common Toxicity Criteria Scoring

Geprüfte Regime

Hyperthermie Register:
die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C), die Dauer der Anwendung und die simultane Therapie mit Chemo- und/oder Strahlentherapie

Quelle: ClinicalTrials.gov