Clinical trial · Interventional
Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
- 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)
This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| stealth liposomal doxorubicin | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- non platinum based chemotherapy
- description
- a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression
- interventionNames
- Drug: stealth liposomal doxorubicin
- Drug: carboplatin
- Drug: paclitaxel
- Drug: Topotecan
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- platinum based chemotherapy
- description
- platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression
- interventionNames
- Drug: stealth liposomal doxorubicin
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of ovarian cancer * Disease recurrence between 6 and 12 months after a first-line platinum based therapy * Indication for chemotherapy, but no more than 2 previous lines of previous therapy * Life expectancy of more than 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) * ECOG Performance Status at least 3 * Previous treatment with stealth liposomal doxorubicin * Residual peripheral neuropathy Grade 3 or higher * 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 no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 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)
- DERIVEDPiccirillo MC, Scambia G, Bologna A, Signoriello S, Vergote I, Baumann K, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Gallo C, Pignata S, Perrone F. Quality-of-life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer. Ann Oncol. 2018 May 1;29(5):1189-1194. doi: 10.1093/annonc/mdy062. PMID 29462248