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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | 3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative |
|
| A2 | Experimental | 2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemotherapy (Carboplatin/Docetaxel) | Procedure | 3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative reduction of ascites volume | preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Pölcher, MD | Contact | +49 228 287 | 15449 | martin.poelcher@ukb.uni-bonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Walther C Kuhn, Prof. MD | University of Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaecolgy and Obstetrics, University hopsital | Recruiting | Bonn | Bonn | 53105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20388201 | Derived | Polcher M, Rudlowski C, Friedrichs N, Mielich M, Holler T, Wolfgarten M, Kubler K, Buttner R, Kuhn W, Braun M. In vivo intratumor angiogenic treatment effects during taxane-based neoadjuvant chemotherapy of ovarian cancer. BMC Cancer. 2010 Apr 13;10:137. doi: 10.1186/1471-2407-10-137. | |
| 20087581 | Derived | Polcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kubler K, Buttner R, Kuhn WC, Hernando JJ. Foxp3(+) cell infiltration and granzyme B(+)/Foxp3(+) cell ratio are associated with outcome in neoadjuvant chemotherapy-treated ovarian carcinoma. Cancer Immunol Immunother. 2010 Jun;59(6):909-19. doi: 10.1007/s00262-010-0817-1. Epub 2010 Jan 20. |
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| neoadjuvant chemotherapy (Carboplatin/Docetaxel) | Procedure | 2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative |
|
| Department of Gynaecology, University hospital | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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