Ovarian Neoplasms
Conditions
Brief summary
Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population.
Interventions
DRUGDocetaxel
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed epithelial ovarian carcinoma. Patients with peritoneal carcinomatosis are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting, and that there is no evidence of a primary fallopian tube cancer (see
Exclusion criteria
). * Female, aged 18 or over- FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface of the ovary * Patients with ruptured capsule as the only evidence of stage Ic will not be eligible for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated. | — |
Countries
South Korea
Outcome results
None listed