Status:
UNKNOWN
MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplati...
Detailed Description
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The high mortality rate is due to the late diagnosis of this malignancy that often develops without symptoms, as wel...
Eligibility Criteria
Inclusion
- Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer
- Indication for chemotherapy treatment
- Age 75 years or less
- Life expectancy of at least 3 months
Exclusion
- Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- Performance status (ECOG) \> 2
- Previous chemotherapy treatment
- Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
- Leukocytes \< 4000/mm3, neutrophils \< 2000/mm3, platelets \< 100000/mm3
- Impaired renal function (creatinine \> 1.25 times the upper normal limit) or liver function (SGOT or SGPT \> 1.25 times the upper normal limit)
- Present or suspected hemorrhagic syndromes
- Uncooperative and/or unreliable patients
- Patient's inability to access the center
- Refusal of informed consent
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00326456
Start Date
January 1 2003
End Date
December 1 2023
Last Update
March 27 2023
Active Locations (38)
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1
Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy, 83100
2
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
3
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
4
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126