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

NCT ID: NCT00551577

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Ovarian Neoplasms

Keywords

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Ovarian neoplasms, Neoadjuvant Therapy, Docetaxel, Neoplasm, Residual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

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

Group Type ACTIVE_COMPARATOR

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Intervention Type PROCEDURE

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

A2

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

Group Type EXPERIMENTAL

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Intervention Type PROCEDURE

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

Interventions

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neoadjuvant chemotherapy (Carboplatin/Docetaxel)

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

Intervention Type PROCEDURE

neoadjuvant chemotherapy (Carboplatin/Docetaxel)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Principal Investigators

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Walther C Kuhn, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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Department of Gynaecolgy and Obstetrics, University hopsital

Bonn, Bonn, Germany

Site Status RECRUITING

Department of Gynaecology, University hospital

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Pölcher, MD

Role: CONTACT

Phone: +49 228 287

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 20388201 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20087581 (View on PubMed)

Other Identifiers

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PRIMOVAR-1

Identifier Type: -

Identifier Source: org_study_id