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Sponsors and Collaborators: |
University Hospital, Bonn Sanofi-Aventis |
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Information provided by: | University Hospital, Bonn |
ClinicalTrials.gov Identifier: | NCT00551577 |
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.
Condition | Intervention | Phase |
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Ovarian Neoplasms |
Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV |
Estimated Enrollment: | 100 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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A1: Active Comparator
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
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Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
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A2: Experimental
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
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Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martin Pölcher, MD | +49 228 287 ext 15449 | martin.poelcher@ukb.uni-bonn.de |
Germany | |
Department of Gynaecolgy and Obstetrics, University hopsital | Recruiting |
Bonn, Germany, 53105 | |
Sub-Investigator: Martin Pölcher, MD | |
Department of Gynaecology, University hospital | Recruiting |
Hamburg, Germany, 20246 | |
Sub-Investigator: Sven Mahner, MD |
Principal Investigator: | Walther C Kuhn, Prof. MD | University Hospital, Bonn |
Study ID Numbers: | PRIMOVAR-1 |
Study First Received: | October 30, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00551577 History of Changes |
Health Authority: | Germany: Ethics Commission; Germany: Local health authority of Bonn |
Ovarian neoplasms, Neoadjuvant Therapy, Docetaxel, Neoplasm, Residual |
Neoplasm, Residual Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Carboplatin Genital Diseases, Female Docetaxel Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Carboplatin |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms |