Public trial registry of the CCC-Munich

Trial AGO- GYN 7

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
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Trial acronym
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AGO- GYN 7
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Full title
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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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Description
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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 number
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Responsible organization
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KUM - GYN - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe (Großhadern) Lmu
Indications
Classification Code Description
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
Trial design
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Trial type
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Interventional
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Blinding type
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Open
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Phase
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II
Status
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Status
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Trial finished
Votes
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Institutional review board - vote
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Unknown
Initiiation & lock
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Date of lock (planned / actual)
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Unknown / 2011-11-01
Participants The lead of this trial has not explicitely given their approval for publishing the contact information of the principal investigators or specific contact persons.