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

Completed

• Conditions: Cancer; Ovarian cancer; Malignant neoplasm of the ovary

• Registration Number: ISRCTN79708370
• Lead Sponsor: TweeSteden Hospital (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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

Exclusion Criteria

Does not comply with the above inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Able to undergo chemotherapeutic regime.

Secondary Outcome Measures

Name	Time	Method
1. Mortality<br>2. Functional decline<br>3. Preserved mobility