Clinical trial · Interventional
Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
NCT00660842CI-TRIAL-00065002MITO-7unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- weekly chemotherapy
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- every 3 weeks chemotherapy
- interventionNames
- Procedure: carboplatin
- Drug: paclitaxel
Primary outcomes (2)
- measure
- quality of life
- timeFrame
- weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- RESULTPignata 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. PMID 24582486