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

Phase 2

• Conditions: Ovarian Neoplasms
• Interventions: Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

• Registration Number: NCT00551577
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Last Update Submitted: 2007-10-30
• Study First Posted: 2007-10-31
• Last Update Posted: 2007-10-31
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	neoadjuvant chemotherapy (Carboplatin/Docetaxel)	3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
A2	neoadjuvant chemotherapy (Carboplatin/Docetaxel)	2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Primary Outcome Measures

Name	Time	Method
Preoperative reduction of ascites volume	preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)

Secondary Outcome Measures

Name	Time	Method
Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL	6 months

Trial Locations

Locations (2)

Department of Gynaecology, University hospital; 🇩🇪 Hamburg, Germany

Department of Gynaecolgy and Obstetrics, University hopsital; 🇩🇪 Bonn, Germany