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This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthermia | Experimental | Patients will receive 6-8 treatments additional loco-regional hyperthermia concurrent to re-irradiation. Hyperthermia will start on the third day of fractionated radiotherapy and will be given twice per week. According to site of recurrent disease either deep-regional, capacitive or superficial hyperthermia devices may be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loco-regional hyperthermia | Device | loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor recurrence | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival after start of re-irradiation | 3 years |
| Progression-free survival | Progression-free survival after start of re-irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Zschaeck, MD | Contact | +4930450650764 | sebastian.zschaeck@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Zschaeck, MD | Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik fĂĽr Radioonkologie und Strahlentherapie | Berlin | 13353 | Germany |
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Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
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| 3 years |
| Freedom from distant metastases | Freedom from distant metastases after start of re-irradiation | 3 years |
| Patient reported quality of Life | patient reported quality of life measured by the EORTC qlq-c30 questionnaire. | 3 years |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D011471 | Prostatic Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D001005 | Anus Neoplasms |
| D012509 | Sarcoma |
| D012004 | Rectal Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000084462 | Hyperthermia |
| D005334 | Fever |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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