Clinical trial · Observational
Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer
Comparison of Real-World Effectiveness of Pegylated Liposomal Doxorubicin Versus Paclitaxel in Platinum- Sensitive Recurrent Ovarian Cancer
NCT03562533CI-TRIAL-00037359completedClinicalTrials.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)
This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.
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 Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin + paclitaxel (CP) | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| pegylated liposomal doxorubicin (PLD) + carboplatin (CD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- pegylated liposomal doxorubicin + carboplatin
- description
- carboplatin area under the curve \[AUC\] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks
- interventionNames
- Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD)
- label
- paclitaxel + carboplatin
- description
- carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks
- interventionNames
- Drug: carboplatin + paclitaxel (CP)
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 36 months
- description
- OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Previous taxane therapy was required. * Recurred \>6 months after surgery and first-line platinum-based chemotherapy regimen * Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or CA-125 assessable disease according to Gynecologic Cancer InterGroup (GCIG) criteria or histologic proven diagnosis * Eastern Cooperative Oncology Group performance status of ≤ 2 Exclusion Criteria: * Had ovarian tumors of low malignant potential (borderline tumors); nonepithelial or mixed epithelial/nonepithelial tumors (eg, mixed Mullerian tumors) * Had received prior radiotherapy; or, had a previous diagnosis of malignancy within the past 5 years. * Had bowel obstruction or presence of symptomatic brain metastases * Patients with severe active infection * Had history of severe hypersensitivity reactions to compounds chemically related to study products.
References
Publications (1)
- DERIVEDPark SJ, Kim J, Kim HS, Lee JW, Chang HK, Lee KH, Kim DY, Kim S, Chang SJ, Han SS, Park SY, Shim SH. Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study. J Gynecol Oncol. 2020 Mar;31(2):e15. doi: 10.3802/jgo.2020.31.e15. Epub 2019 Sep 10. PMID 31912673