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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
* Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br>3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative | Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)<br>* 3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative<br>|
| Experimental: A2<br>2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative | Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)<br>* 2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative reduction of ascites volume |  | preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian neoplasms,, Neoadjuvant Therapy,, Docetaxel,, Neoplasm, Residual