Clear Cell Carcinoma of the Ovary MedDRA version: 9.1 Level: LLT Classification code 10033131 Term: Ovarian carcinoma
Conditions
Interventions
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Kitasato institute clinical trial coordinating center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a histological diagnosis of clear cell carcinoma of the ovary, FIGO stages I to IV. All patients must have had appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. In cases with concurrent presence of other histological cell types, clear cell histology must be dominant (>50%). Histology will be confirmed by central pathology review prior to registration. Age: 18 or older ECOG performance status 0-1 Reasonable organ function Patient must have signed informed consent Patients must be enrolled within 6 weeks after comprehensive staging surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with a current diagnosis of epithelial ovarian tumour of low malignant potential (borderline carcinomas) Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer Prior chemotherapy or radiation therapy to treat the current disease Patients who received intraperitoneal chemotherapy at the time of operation Prior diagnosis of malignancy (other than non-melanoma skin cancer or other malignancies curatively treated and > 5 years without evidence of recurrence) Patients who have received prior radiotherapy (exceptions are: prior radiation for localized cancer of the breast, head and neck or skin is permitted, provided that it was completed more than 5 years prior to registration, and that the patient remains free of recurrent or metastatic disease) Patients who have received prior chemotherapy (exceptions are: patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare effectiveness and safety of the two chemotherapy regimens in patients with stages I,II,III and IV clear cell carcinoma of the ovary;Secondary Objective: ;Primary end point(s): Progression Free Survival Overall survival Response Rate Adverse Events (Frequency and grade) | — |
Countries
France, Italy, United Kingdom
Outcome results
None listed