ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO Stage III
Conditions
Interventions
Product Name: cisplatinum
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age between 18 and 76 years 2. histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid andenocarcinoma. 3. in case of pleural effusion cytology should be negative for tumour cells 4. In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply: ? Normal mammogram ( 200 kU/l and ? Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is 1 cm 6. In case of primary chemotherapy: - chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol - Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1) 7. In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy: - chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol 8.General criteria: - Fit for major surgery, ASA 1 or ASA 2 - WHO performance status 0-2 - Written informed consent - Laboratory values: serum creatinine 60 ml/min (Cockroft formula) ; white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l 9. For quality of life studies: - baseline questionnaires should be filled in before randomization 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: creatinin clearance < 60 ml/min according to Cockcroft-Gault formula - history of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are comparing the duration of progression free survival following completion of treatment between the 2 study arms. ;Secondary Objective: Secondary objectives of this study involves toxicity and morbidity, quality of life, tumour response following treatment and overall survival of the study arm compared to the standard arm. ;Primary end point(s): Main endpoint in this trial is progression-free-survival (PFS), e.g. the time between randomization, just before debulking, and progression of disease or death of any cause, whichever occurs first. Patients still alive at the time of the analysis with no evidence of disease at the time of their last visit are censored at the date of the most recent follow-up. Progression of disease is defined as: Radiological evidence of an increase iof 20% in the size of residual lesion(s) or the occurrence of new lesions according the RECIST criteria (see appendix 10) and/or CA 125 elevations according to the GCIG criteria (see appendix 10) | — |
Countries
Netherlands
Outcome results
None listed