Ovarian cancer FIGO IIB-IV
Conditions
Interventions
CGA, using predefined cutoff points in MMSE, ADL-score, IADL-score en comorbidity-index.
Sponsors
TweeSteden hospital, location Tilburg
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological confirmed (extra) epithelial ovarian carcinoma FIGO IIB - IV. Tumors of borderline malignancy are excluded; 2. No prior treatment with cytostatic agents or radiotherapy; 3. Age ¡Ý 70 years; 4. Performance status 0-2; 5. Life expectancy ¡Ý 3 months; 6. Able to undergo protocol treatment according to clinical judgment of the medical oncologist; 7. No second primary malignancy except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or a prior cancer cured with surgery alone and with a disease-free interval of longer than 5 years; 8. Adequate hematological, renal and hepatic function as defined by the following required laboratory values (obtained ¡Ü 14 days prior to study enrollment): a. WBC ¡Ý 3.0x109/L; b. Platelets ¡Ý 100x109/L; c. Calculated creatinine clearance ¡Ý 40 ml/min (according to the Cockroft and Gault formula), see 9.3; d. Serum bilirubin ¡Ü 1.5 x upper normal limit; e. SGOT (AST) and/or SGPT (ALT) ¡Ü 2.5 x upper normal limit; 9. Absence of significant cardiac disease, i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year, or cardiac ventricular arrhythmias requiring medication. History of 2nd and 3rd degree heart blocks without pacemaker in situ; 10. No active infection, major medical illness, signs or symptoms of CNS involvement or leptomeningeal disease; 11. No known hypersensitivity reactions to any of the components of the treatment, including cremophor; 12. Absence of CTC grade ¡Ý 1 peripheral neurotoxicity; 13. Assessable for treatment and follow-up; 14. Informed consent.
Exclusion criteria
Exclusion criteria: No exclusion criteria mentioned in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Able to undergo chemotherapeutic regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality; 2. Functional decline; 3. Preserved mobility. | — |
Contacts
Public ContactH.A.A.M. Maas
TweeSteden hospital, Location Tilburg, P.O. Box 90107
Outcome results
None listed