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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00551577

Acronym

PRIMOVAR-1

Enrollment

100

Registered

2007-10-31

Start date

2003-03-31

Completion date

2008-01-31

Last updated

2007-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

Keywords

Ovarian neoplasms,, Neoadjuvant Therapy,, Docetaxel,, Neoplasm, Residual

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.

Interventions

PROCEDUREneoadjuvant chemotherapy (Carboplatin/Docetaxel)

3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactMartin Pölcher, MD

martin.poelcher@ukb.uni-bonn.de+49 228 287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026