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

NCT00551577UNKNOWNPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University Hospital, Bonn

Enrollment

100

Start Date

2003-03-01

Study Type

INTERVENTIONAL

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

Interventions

neoadjuvant chemotherapy (Carboplatin/Docetaxel)neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Preoperative reduction of ascites volume

Time frame: preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)

Secondary Outcomes

Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL

Time frame: 6 months

Locations

Department of Gynaecolgy and Obstetrics, University hopsital, Bonn, Germany

Department of Gynaecology, University hospital, Hamburg, Germany

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