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Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Arm | Other | 1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2) Chemotherapy: 5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3 Chemotherapy: Cisplatin 20mg/m^2; d1-5, 29-33 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermia | Other | Deep Regional Hyperthermia (RHT) 1-2/week up to 10 sessions a type of cancer treatment in which body tissue is exposed to high temperatures (up to 113°F). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival | Participants will be followed for up to 5 years after the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder preservation rate | Rate of patients where bladder can be preserved | Participants will be followed for up to 5 years after the end of therapy |
| Disease free survival | Length of survival without disease recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Ott, MD | Contact | ++49(0)913185 | 33968 | oliver.ott@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Ott, MD | Dept. of Radiation Therapy, University Hospital Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Radiation Therapy, University Hospital Erlangen | Recruiting | Erlangen | 91054 | Germany |
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|
| Radiotherapy | Radiation | 50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy |
|
| Chemotherapy 5-Fluorouracil | Drug | 600 mg/m^2 civ 120h; d 1-5, 29-33 |
|
| Chemotherapy Cisplatin | Drug | 20 mg/m^2; d1-5, 29-33 |
|
| Participants will be followed for up to 5 years after the end of therapy |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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