HTRegister: Prospective Hyperthermia Database in Cancer Patients (HT Register)
Study Details
Study Description
Brief Summary
This monocentric study registry records all cancer patients at the Charité which are treated with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the general application and to obtain an accurate risk-benefit balance
After confinement in this database are the patients prospectively in order to complications, disease status and survival status tracked.
Furthermore there is the possibility in the course of this study to an optional take part in translational accompanying research with the aim of prognostic factors for response to hyperthermia treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hyperthermie Register Hyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Effectivity [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
- Toxicity [Through the study completion, up to 10 years]
Toxicity assessment based on Common Toxicity Criteria Scoring
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Contrazeption with female patients at the capable of bearing children age
-
Written agreement is present (DvH, ICH-GCP)
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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.
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With children must the treatment with one of the GPOH agreed Pattern take place
Exclusion Criteria:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic for Radio - Oncology and Radiotherapy | Berlin | Germany | 13353 | |
| 2 | Clinic for Radio - Oncology and Radiotherapy | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Pirus Ghadjar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HTRegister2014