Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT00368420 |
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Recruitment Status :
Completed
First Posted : August 24, 2006
Last Update Posted : February 15, 2011
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| Condition or disease |
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| Ovarian Cancer |
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 : | Observational |
| Actual Enrollment : | 122 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer |
| Study Start Date : | September 2006 |
| Actual Primary Completion Date : | July 2008 |
| Actual Study Completion Date : | October 2009 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368420
| Austria | |
| Universitätskliniken LKH Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| University Hospitals Leuven | |
| Leuven, Belgium, 3000 | |
| Germany | |
| Klinikum der Johann Wolfgang Goethe Universität | |
| Frankfurt, Germany, 60596 | |
| Universitätsklinikum Freiburg | |
| Freiburg, Germany, 79106 | |
| St. Vincentius Kliniken gAG | |
| Karlsruhe, Germany, 76135 | |
| Klinikum Landshut gGmbH | |
| Landshut, Germany, 84034 | |
| Städtisches Krankenhaus Lüneburg | |
| Lüneburg, Germany, 21339 | |
| Klinikum Neumarkt | |
| Neumarkt, Germany, 92318 | |
| HSK, Dr. Horst Schmidt Klinik | |
| Wiesbaden, Germany, 65199 | |
| Klinikum der Stadt Wolfsburg | |
| Wolfsburg, Germany, 38440 | |
| Italy | |
| Catholic University of Sacred Heart | |
| Campobasso, Italy, 86100 | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00368420 |
| Other Study ID Numbers: |
AGO-OVAR OP.2 AGO DESKTOP OVAR II |
| First Posted: | August 24, 2006 Key Record Dates |
| Last Update Posted: | February 15, 2011 |
| Last Verified: | February 2011 |
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ovarian cancer recurrence surgery |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma |