NCT00551577

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

October 30, 2007

Last Update Submit

October 30, 2007

Conditions

Ovarian Neoplasms

Keywords

Ovarian neoplasms,Neoadjuvant Therapy,Docetaxel,Neoplasm, Residual

Outcome Measures

Primary Outcomes (1)

  • Preoperative reduction of ascites volume

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

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

A1

ACTIVE COMPARATOR

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

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

A2

EXPERIMENTAL

2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Interventions

neoadjuvant chemotherapy (Carboplatin/Docetaxel)PROCEDURE

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

A1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gynaecolgy and Obstetrics, University hopsital

Bonn, Bonn, 53105, Germany

RECRUITING

Department of Gynaecology, University hospital

Hamburg, Hamburg, 20246, Germany

RECRUITING

Related Publications (2)

  • Polcher M, Rudlowski C, Friedrichs N, Mielich M, Holler T, Wolfgarten M, Kubler K, Buttner R, Kuhn W, Braun M. In vivo intratumor angiogenic treatment effects during taxane-based neoadjuvant chemotherapy of ovarian cancer. BMC Cancer. 2010 Apr 13;10:137. doi: 10.1186/1471-2407-10-137.

    PMID: 20388201DERIVED

  • Polcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kubler K, Buttner R, Kuhn WC, Hernando JJ. Foxp3(+) cell infiltration and granzyme B(+)/Foxp3(+) cell ratio are associated with outcome in neoadjuvant chemotherapy-treated ovarian carcinoma. Cancer Immunol Immunother. 2010 Jun;59(6):909-19. doi: 10.1007/s00262-010-0817-1. Epub 2010 Jan 20.

    PMID: 20087581DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasm, Residual

Interventions

Neoadjuvant TherapyCarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Walther C Kuhn, Prof. MD

    University of Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Pölcher, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

March 1, 2003

Study Completion

January 1, 2008

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

DE(2)