NCT02728622

Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Detailed description

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).

Conditions

• Ovarian Cancer
• Peritoneal Cancer
• Cancer of the Fallopian Tube

Interventions

Type	Name	Description
DRUG	Tamoxifen	endocrine treatment
DRUG	Chemotherapy	Paclitaxel or pegylated liposomal doxorubicin

Timeline

• Start date: 2002-03-01
• Primary completion: 2008-01-01
• Completion: 2009-01-01
• First posted: 2016-04-05
• Last updated: 2016-04-05