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…
ID
Bron
Verkorte titel
Aandoening
Ovarian cancer FIGO IIB-IV
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Able to undergo chemotherapeutic regime.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
CGA, using predefined cutoff points in MMSE, ADL-score, IADL-score en comorbidity-index.
Algemeen / deelnemers
P.O. Box 90107
H.A.A.M. Maas
Tilburg 5000 LA
The Netherlands
+31 (0)13 4655111
hmaas@tsz.nl
Wetenschappers
P.O. Box 90107
H.A.A.M. Maas
Tilburg 5000 LA
The Netherlands
+31 (0)13 4655111
hmaas@tsz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
No exclusion criteria mentioned in the protocol.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL405 |
NTR-old | NTR445 |
Ander register | CCMO : P03.1456 L |
ISRCTN | ISRCTN79708370 |
Samenvatting resultaten
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.