Öffentliches Studienregister des CCC-München

Studie AGO- GYN 7

Studie Studiendesign Status Ein-/Auschlusskriterien Therapie Teilnehmer Dokumente Berechtigungen Tumorboards

Studie
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Studienakronym
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AGO- GYN 7
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Vollständiger Titel
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Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors

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Beschreibung
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Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in patients with advanced or metastatic disease.

Ovarian carcinosarcoma is extremely rare among ovarian malignancies (< 2%). That is why there is insufficient data as a basis for establishing a gold standard. As a result, these cases tend to be treated in the same way as uterine sarcomas or epithelial ovarian malignancies in clinical practice.

On the basis of data published to date on the treatment of mixed mesenchymal-epithelial tumors, it is clear that the treatments commonly used to date have limited activity while producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide, Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of withdrawals due to toxicity was in a study collective of selected females treated with the last combination at 40 %. The physician has to check in every individual case if one of the above mentioned combinations is feasible. The search for alternative effective and better tolerated treatment options is essential. The toxicity data on the carboplatin-PLD combination are known, and efficacy has been identified in small cohorts.

The objective of this study is to explore the efficacy of combination PLD-carboplatin treatment in a larger patient population.

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NCT-Nr.
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Zuständige Einrichtung
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KUM - GYN - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe (Großhadern) Lmu
Krankheitsentitäten
Klassifikation Code Beschreibung
ICD-10-GM D48.1 Bindegewebe und andere Weichteilgewebe
ICD-10-GM C54.9 Corpus uteri, nicht näher bezeichnet
ICD-10-GM C49.9 Bindegewebe und andere Weichteilgewebe, nicht näher bezeichnet
Studiendesign
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Studientyp
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Interventionsstudie
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Verblindungstyp
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Offen
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Studienphase
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II
Status
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Status
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Studie beendet
Voten
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Ethikkommission - Votum
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Unbekannt
Initiierung & Abschluß
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Abschlussdatum (Plan / Ist)
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Unbekannt / 2011-11-01
Teilnehmer Die Studienleitung hat einer Freigabe der Kontaktdaten der Hauptprüfer bzw. Hauptansprechpartner nicht explizit zugestimmt.