Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
NCT ID: NCT00660842
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
800 participants
INTERVENTIONAL
2008-11-30
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
weekly chemotherapy
carboplatin
AUC 2 IV every week
paclitaxel
60mg/m2 IV every week
B
every 3 weeks chemotherapy
carboplatin
AUC 6 IV day 1 every 21 days
paclitaxel
175 mg/m2 IV day 1 every 21 days
Interventions
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carboplatin
AUC 6 IV day 1 every 21 days
paclitaxel
175 mg/m2 IV day 1 every 21 days
carboplatin
AUC 2 IV every week
paclitaxel
60mg/m2 IV every week
Eligibility Criteria
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Inclusion Criteria
* Indication for chemotherapy
* Age \> 18 years
* Life expectancy of at least 3 months
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Sandro Pignata, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Marilina Piccirillo, M.D.,
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
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IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy
Azienda Ospedaliera C. Poma
Mantova, MN, Italy
Azienda Ospedaliera V. Cervello
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy
Ospedale S. Chiara
Trento, TN, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy
Ospedale Mazzoni
Ascoli Piceno, , Italy
Policlinico Universitario
Bari, , Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
Bari, , Italy
Ospedale Fatebenefratelli
Benevento, , Italy
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Universita Cattolica del Sacro Cuore
Campobasso, , Italy
Ospedale A. Manzoni
Lecco, , Italy
Istituto Nazionale Tumori
Milan, , Italy
A.O. Univeristaria Policlinico
Modena, , Italy
Azienda Ospedaliera D. Cotugno
Napoli, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, , Italy
Università Federico II, Cattedra di Oncologia Medica
Napoli, , Italy
Ospedale Silvestrini
Perugia, , Italy
Ospedale Civile S. Spirito
Pescara, , Italy
A.O. S. Maria degli Angeli
Pordenone, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
Roma, , Italy
A.O. di Udine S. Maria della Misericordia
Udine, , Italy
Countries
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References
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Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28.
Other Identifiers
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2008-001754-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MITO-7
Identifier Type: -
Identifier Source: org_study_id
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