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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001754-40 | EudraCT Number |
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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 to those treated with standard every 3 weeks schedule of the same chemotherapy.
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 it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | weekly chemotherapy |
|
| B | Active Comparator | every 3 weeks chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Procedure | AUC 6 IV day 1 every 21 days |
| |
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy | |
| progression free survival | every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 24 months | |
| response rate | after 9 and 18 weeks of therapy | |
| toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandro Pignata, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Francesco Perrone, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Marilina Piccirillo, M.D., | National Cancer Institute, Naples | Principal Investigator |
| Ciro Gallo, M.D., Ph.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Oncologico Bari, Oncologia Medica | Bari | BA | 70126 | Italy | ||
| Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24582486 | Result | 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. |
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| Drug |
175 mg/m2 IV day 1 every 21 days |
|
| carboplatin | Drug | AUC 2 IV every week |
|
| paclitaxel | Drug | 60mg/m2 IV every week |
|
| weekly during therapy |
| describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis | at study entry |
| describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) | at study entry |
| describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' | at study entry |
| Bergamo |
| BG |
| 24128 |
| Italy |
| Ospedale Fatebenefratelli, U.O. di Oncologia | Benevento | BN | 82100 | Italy |
| Azienda Ospedaliera G. Rummo | Benevento | BN | Italy |
| Università Cattolica del Sacro Cuore, Dipartimento di Oncologia | Campobasso | CB | 86100 | Italy |
| Azienda Ospedaliera C. Poma | Mantua | MN | 46100 | Italy |
| Azienda Ospedaliera V. Cervello | Palermo | PA | Italy |
| Ospedale S. Massimo, Day Hospital Oncologico | Penne | PE | 65017 | Italy |
| Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C | Aviano | PN | 33081 | Italy |
| Ospedale S. Chiara | Trento | TN | 38100 | Italy |
| Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica | Vicenza | VI | 36100 | 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 | Naples | 80131 | Italy |
| Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico | Naples | 80131 | Italy |
| Università Federico II, Cattedra di Oncologia Medica | Naples | 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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