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

ISRCTN	ISRCTN79708370
DOI	https://doi.org/10.1186/ISRCTN79708370
Protocol serial number	CCMO no.: P03.1456 L; NTR445
Sponsor	TweeSteden Hospital (The Netherlands)
Funders	Amgen Europe B.V. (The Netherlands), Bristol-Myers Squibb (USA), TweeSteden Hospital (The Netherlands)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 20/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H A A M Maas
Scientific

TweeSteden Hospital
Location Tilburg
P.O. Box 90107
Tilburg
5000 LA
Netherlands

Phone	+31 (0)13 465 5111
Email	hmaas@tsz.nl

Study information

Primary study design	Observational
Study design	Observational multicentre trial
Secondary study design	Multi-centre
Scientific title
Study acronym	CGA-trial
Study objectives	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
Ethics approval(s)	Approval received from the local ethics board (Medisch-Ethische Toetsing Onderzoek patienten en Proefpersonen [METOPP]) on the 26th October 2003, approval amendement 22nd August 2005 (ref: P03.1456L).
Health condition(s) or problem(s) studied	Ovarian cancer
Intervention	CGA, using predefined cutoff points in Mini Mental State Examination (MMSE), Activities of Daily Living (ADL)-score, Instrumental Activities of Daily Living (IADL)-score and comorbidity-index.
Intervention type	Other
Primary outcome measure(s)	Able to undergo chemotherapeutic regime.
Key secondary outcome measure(s)	1. Mortality 2. Functional decline 3. Preserved mobility
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	60
Key inclusion criteria	1. Histological confirmed (extra) epithelial ovarian carcinoma International Federation of Gynaecology and Obstetrics (FIGO) grade IIB - IV. Tumours of borderline malignancy are excluded. 2. No prior treatment with cytostatic agents or radiotherapy 3. Age greater than or equal to 70 years 4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two 5. Life expectancy greater than or equal to three 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 five years 8. Adequate haematological, renal and hepatic function as defined by the following required laboratory values (obtained less than or equal to 14 days prior to study enrolment): 8.1. White blood cells (WBC) greater than or equal to 3.0 x 10^9/L 8.2. Platelets greater than or equal to 100 x 10^9/L 8.3. Calculated creatinine clearance greater than or equal to 40 ml/min (according to the Cockroft and Gault formula) 8.4. Serum bilirubin less than or equal to 1.5 x upper normal limit 8.5. Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and/or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) less than or equal to 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 second and third degree heart blocks without pacemaker in situ. 10. No active infection, major medical illness, signs or symptoms of central nervous system (CNS) involvement or leptomeningeal disease 11. No known hypersensitivity reactions to any of the components of the treatment, including cremophor 12. Absence of common toxicity criteria (CTC) grade greater than or equal to one peripheral neurotoxicity 13. Assessable for treatment and follow-up 14. Informed consent
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/05/2004
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

TweeSteden Hospital

Tilburg
5000 LA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan