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 |
| Secondary identifying numbers | CCMO no.: P03.1456 L; NTR445 |
- 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
Scientific
TweeSteden Hospital
Location Tilburg
P.O. Box 90107
Tilburg
5000 LA
Netherlands
| Phone | +31 (0)13 465 5111 |
|---|---|
| hmaas@tsz.nl |
Study information
| Study design | Observational multicentre trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | Able to undergo chemotherapeutic regime. |
| Secondary outcome measures | 1. Mortality 2. Functional decline 3. Preserved mobility |
| Overall study start date | 01/05/2004 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 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
5000 LA
Netherlands
Sponsor information
TweeSteden Hospital (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Location Tilburg
P.O. Box 90107
Tilburg
5000 LA
Netherlands
"ROR" |
https://ror.org/04gpfvy81 |
|---|
Funders
Funder type
Industry
Amgen Europe B.V. (The Netherlands)
No information available
Bristol-Myers Squibb (USA)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Bristol-Myers Squibb Company, BMS
- Location
- United States of America
TweeSteden Hospital (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
