- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368420
Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
Study Overview
Status
Conditions
Detailed Description
The multicentre retrospective study AGO-DESKTOP OVAR 1 investigated in a multicentre-setting the question of prognostic factors for a successful (i.e. complete) debulking for recurrence. That way, a hypothesis for a score with 3 factors could be developed:
- PS ECOG = 0
- tumor-free after primary surgery (if unknown: FIGO I/II)
- Ascites < 500 ml.
The goal of this study is to evaluate in a prospective multicentre setting, to what extent this retrospectively defined AGO-score has predictive validity. The criterion aimed at is therefore the rate of complete tumor resections if the three score characteristics are present in invasive epithelial platinum-sensitive ovarian-, fallopian tube- or primary peritoneal cancer. This study will be the second in a series of three: (1) hypothesis building for a potential predictive score for resectability, (2) prospective confirmation of the AGO-score, and (3) application of the AGO-score as inclusion criteria for eligible patients in whom a formal comparison of the role of secondary debulking of relapsed ovarian cancer could be performed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Innsbruck, Austria, 6020
- Universitätskliniken LKH Innsbruck
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Leuven, Belgium, 3000
- University Hospitals Leuven
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Frankfurt, Germany, 60596
- Klinikum der Johann Wolfgang Goethe Universitat
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Freiburg, Germany, 79106
- Universitätsklinikum Freiburg
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Karlsruhe, Germany, 76135
- St. Vincentius Kliniken gAG
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Landshut, Germany, 84034
- Klinikum Landshut gGmbH
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Lüneburg, Germany, 21339
- Städtisches Krankenhaus Lüneburg
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Neumarkt, Germany, 92318
- Klinikum Neumarkt
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Wiesbaden, Germany, 65199
- HSK, Dr. Horst Schmidt Klinik
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Wolfsburg, Germany, 38440
- Klinikum der Stadt Wolfsburg
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Campobasso, Italy, 86100
- Catholic University Of Sacred Heart
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Milan, Italy, 20141
- European Institute of Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.
- Women aged > 18 years
- Patients who have given their signed and written informed consent to data transmission and -processing
Exclusion Criteria:
- Patients with non-epithelial tumors as well as borderline tumors
- Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval
- Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer
- Patients with a third recurrence
- Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philipp Harter, Dr., Dr. Horst Schmidt Klinik Wiesbaden
- Study Chair: Annette Hasenburg, PD Dr., Universitäts-Frauenklinik Freiburg
- Study Director: Andreas du Bois, Prof. Dr., Dr. Horst Schmidt Klinik Wiesbaden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- AGO-OVAR OP.2
- AGO DESKTOP OVAR II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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