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The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Arm | Experimental | Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | 50.4 Gy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (local / distant / overall) | 5 years | |
| Safety by Toxicity assessment according to NCI CTCAE v4.0 | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Ott, MD | Contact | ++49 9131 85 | 33968 | st-studiensekretariat@uk-erlangen.de |
| Rainer Fietkau, MD | Contact | ++49 9131 85 | 33968 | st-studiensekretariat@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen, Strahlenklinik | Recruiting | Erlangen | 91054 | Germany |
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| brachytherapy | Radiation | 35-40 Gy |
|
|
| Cisplatin | Drug | weekly 40 mg/m^2 (6cycles) |
|
| Hyperthermia | Other | 10 times |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital 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 |
|---|---|
| D011827 | Radiation |
| D011878 | Radiotherapy |
| D001918 | Brachytherapy |
| D002945 | Cisplatin |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006979 | Hyperthermia, Induced |
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