A Phase 3 interventional study of Tamoxifen and Chemotherapy in Ovarian Cancer, Peritoneal Cancer and Cancer of the Fallopian Tube, sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-05.
Sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Phase 3, Interventional, and Treatment
A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.
Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 241 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Nordic Society of Gynaecological Oncology - Clinical Trials Unit is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tamoxifen 40 mg is given orally once daily until progression
Drug: Tamoxifen
Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression
Drug: Chemotherapy
endocrine treatment
Paclitaxel or pegylated liposomal doxorubicin
Also known as: paclitaxel, pegylated liposomal doxorubicin
Quality-adjusted survival
Time frame: through completion of study, on average 1 year
progression-free survival
time to progressive disease or death
Time frame: through completion of study, on average 3 months
overall survival
time to death of any cause
Time frame: through completion of study, on average 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Nordic Society of Gynaecological Oncology - Clinical Trials Unit