Condition category
Cancer
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
20/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H A A M Maas

ORCID ID

Contact details

TweeSteden Hospital
Location Tilburg
P.O. Box 90107
Tilburg
5000 LA
Netherlands
+31 (0)13 465 5111
hmaas@tsz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCMO no.: P03.1456 L; NTR445

Study information

Scientific title

Acronym

CGA-trial

Study hypothesis

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

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).

Study design

Observational multicentre trial

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Able to undergo chemotherapeutic regime.

Secondary outcome measures

1. Mortality
2. Functional decline
3. Preserved mobility

Overall trial start date

01/05/2004

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

60

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/05/2004

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

TweeSteden Hospital
Tilburg
5000 LA
Netherlands

Sponsor information

Organisation

TweeSteden Hospital (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Amgen Europe B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bristol-Myers Squibb (USA)

Alternative name(s)

Bristol-Myers Squibb Company, BMS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

TweeSteden Hospital (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes