Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial

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

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.

Inclusion Criteria:

• histological confirmed ovarian neoplasm
• Figo stage IIIC (2cm extrapelvic disease) or Figo IV
• more than 500 ml ascites volume (measured by sonography)
• age > 18 years old
• ECOG <= 2
• adequate hepatological, renal and haematological function
• informed consent

Exclusion Criteria:

• concomitant or previous malignant diseases
• debulking procedures on initial surgical approach
• existing peripheral sensoric neuropathy >= grade 2
• acute infections
• mental disorders, cerebral metastasis
• bowel obstruction