Clinical trial · Interventional
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
NCT01669226CI-TRIAL-00025215AICEcompletedPhase 2ClinicalTrials.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 evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bulky Stage IIIC and IV Epithelial Ovarian Cancer | — | UNRESOLVED | — |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEip (weekly) and TCiv | Drug | — | UNRESOLVED |
| TCiv | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen B, PEip and TCiv therapy
- description
- Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
- interventionNames
- Drug: PEip (weekly) and TCiv
- type
- ACTIVE_COMPARATOR
- label
- Regimen A: Standard TCiv therapy
- description
- IV paclitaxel plus carboplatin or docetaxel plus carboplatin
- interventionNames
- Drug: TCiv
Primary outcomes (1)
- measure
- 12-month disease non-progression rate
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years to ≤ 75 years. * Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone * Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm * Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection. * ECOG performance 0-2. * No more than 3 cycles of chemotherapy prior to surgery. * Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin \< 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min. * Comply with intraperitoneal chemotherapy and follow-up. * Written informed consent. Exclusion Criteria: * Low-malignant potential ovarian tumor. * Laboratory testing insufficiency. Hemoglobin \< 10 g/dL. Renal insufficiency with serum creatinine \> 1.6. * Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3. * Active infection. * Clinically significant gastrointestinal abnormalities. * Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure. * Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up. * Prior invasive malignancies within the last 5 years showing activity of disease.
References
Publications (1)
- DERIVEDShi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6. PMID 31383985