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Clinical Trials/NCT00551577
NCT00551577
Unknown
Phase 2

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

University Hospital, Bonn2 sites in 1 country100 target enrollmentMarch 2003
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ConditionsOvarian Neoplasms

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Ovarian Neoplasms
Sponsor
University Hospital, Bonn
Enrollment
100
Locations
2
Primary Endpoint
Preoperative reduction of ascites volume
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
January 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Bonn

Eligibility Criteria

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

Outcomes

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(6 months)

Study Sites (2)

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