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Value of Comprehensive Geriatric Assessment, clinical judgment, and performance status in the treatment of patients with epithelal ovarian carcinoma aged 70 years and older.


- candidate number1733
- NTR NumberNTR445
- ISRCTNISRCTN79708370
- Date ISRCTN created26-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR27-sep-2005
- Secondary IDsP03.1456 L  CCMO
- Public TitleValue of Comprehensive Geriatric Assessment, clinical judgment, and performance status in the treatment of patients with epithelal ovarian carcinoma aged 70 years and older.
- Scientific TitleValue of Comprehensive Geriatric Assessment (=CGA), clinical judgment, and performance status in the treatment of patients with epithelal ovarian carcinoma aged 70 years and older.
- ACRONYMCGA-trial
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedOvarian cancer
- Inclusion criteria1. 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 70 years;
4. Performance status 0-2;
5. Life expectancy 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 14 days prior to study enrollment):
a. WBC 3.0x109/L;
b. Platelets 100x109/L;
c. Calculated creatinine clearance 40 ml/min (according to the Cockroft and Gault formula), see 9.3;
d. Serum bilirubin 1.5 x upper normal limit;
e. SGOT (AST) and/or SGPT (ALT) 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 1 peripheral neurotoxicity;
13. Assessable for treatment and follow-up;
14. Informed consent.
- Exclusion criteriaNo exclusion criteria mentioned in the protocol.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2004
- planned closingdate1-mei-2007
- Target number of participants60
- InterventionsCGA, using predefined cutoff points in MMSE, ADL-score, IADL-score en comorbidity-index.
- Primary outcomeAble to undergo chemotherapeutic regime.
- Secondary outcome1. Mortality;
2. Functional decline;
3. Preserved mobility.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES H.A.A.M. Maas
- CONTACT for SCIENTIFIC QUERIES H.A.A.M. Maas
- Sponsor/Initiator TweeSteden hospital, location Tilburg
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Bristol-Myers, Squibb, TweeSteden hospital, location Tilburg
- PublicationsMaas HA, Kruitwagen RF, Lemmens VE, Goey SH, Janssen-Heijnen ML. 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.
- Brief summaryObjective:
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.
- Main changes (audit trail)
- RECORD27-sep-2005 - 27-nov-2009


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