Status:
UNKNOWN
Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared t...
Detailed Description
The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make...
Eligibility Criteria
Inclusion
- Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
- Indication for chemotherapy
- Age \> 18 years
- Life expectancy of at least 3 months
Exclusion
- Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
- Performance Status (ECOG) \> or = 3.
- Previous chemotherapy
- Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
- Neutrophils \< 2000 x mm3, platelets \< 100000 x mm3
- Inadequate renal function (creatinine \> or = 1.25 x normal values) or liver function (ALT or AST \> or = 1.25 x normal values)
- Present or suspected hemorrhagic syndromes
- Inability to comply with protocol and follow-up
- Inability to access study site for clinical visits
- Refusal of informed consent
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00660842
Start Date
November 1 2008
End Date
November 1 2024
Last Update
March 24 2023
Active Locations (28)
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1
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
2
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy, 24128
3
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
4
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy