Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
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).
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
Age must be at least 18 years.
Performance status must be 0-2 (WHO/ECOG, appendix 1).
Informed consent given according to ICH/EU GCP guidelines and local or national laws
You may not be if
Patients with symptomatic brain metastasis
Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
Pregnant, lactating, or child bearing potential patients without adequate contraception
Previous treatment with Tamoxifen.
Clareo Health | Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
