No registrations found.
ID
Source
Brief title
Health condition
Ovarian cancer FIGO IIB-IV
Sponsors and support
Intervention
Outcome measures
Primary outcome
Able to undergo chemotherapeutic regime.
Secondary outcome
1. Mortality;
2. Functional decline;
3. Preserved mobility.
Background summary
Objective:
To correlate clinical course, outcome of the disease and toxicities with clinical judgment and CGA in order to better define which components can support future decisions with regard to patient selection and treatment.
Study objective
1. Comprehensive geriatric assessment has no benefits in selecting patients fit for chemotherapeutic treatment, compared to clinical judgement by the medical oncologist;
2. Observational report of the functional outcome of treating ovarian carcinoma in the elderly.
Study design
N/A
Intervention
CGA, using predefined cutoff points in MMSE, ADL-score, IADL-score en comorbidity-index.
P.O. Box 90107
H.A.A.M. Maas
Tilburg 5000 LA
The Netherlands
+31 (0)13 4655111
hmaas@tsz.nl
P.O. Box 90107
H.A.A.M. Maas
Tilburg 5000 LA
The Netherlands
+31 (0)13 4655111
hmaas@tsz.nl
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
No exclusion criteria mentioned in the protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL405 |
NTR-old | NTR445 |
Other | CCMO : P03.1456 L |
ISRCTN | ISRCTN79708370 |
Summary results
Gynecol Oncol. 2005 Apr;97(1):104-9
The influence of age and co-morbidity on treatment and prognosis of ovarian cancer: a population-based study.