A Phase 3 interventional study of Hycamtin and Gemcitabine in Ovarian Cancer, sponsored by North Eastern German Society of Gynaecological Oncology. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-04-11.
Sponsored by North Eastern German Society of Gynaecological Oncology · Phase 3, Interventional, and Treatment
Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.
In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 450 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →North Eastern German Society of Gynaecological Oncology is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
overall survival
time to progression
determining adverse effects
quality of life
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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North Eastern German Society of Gynaecological Oncology