Clinical trial · Interventional
Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study stopped due to slow accrual.
Summary
Brief summary (as posted)
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer. Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy. Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer. We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel 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 Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IP chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IP Chemotherapy
- description
- Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
- interventionNames
- Drug: IP chemotherapy
Primary outcomes (1)
- measure
- 2 year progression-free survival rate.
- timeFrame
- 2 Year after initial surgery
- description
- The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation.
Secondary outcomes (3)
- measure
- Median overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. Age \>=20 and \<=75 2. Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer 3. Stage 3 or 4 4. WBC \>= 3500/mm3, ANC \>= 1500/mm3, platelet \>= 100000/mm3, hemoglobin \>= 10 g/dl 5. Serum creatinine \<= upper normal limit \* 1.25 6. Total bilirubin \<= 1.5mg/mm3, ALT/AST \<= upper normal limit \* 3, ALP \<= upper normal limit \* 3 7. Adequate compliance and geographical closeness which make adequate follow-up possible 8. GOG performance status 0-2 9. Anticipated survival \>= 3 months 10. Who agreed to participate in this study and signed on informed consent form Exclusion criteria: 1. History of chemotherapy or radiotherapy on abdomen/pelvis area 2. Pleural/pericardial effusion, ascites causing respiratory difficulties \>= NCI-CTCAE grade 2 3. History of other cancers within 5 years 4. History of unapproved therapy within 30 days before enrollment 5. Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.
References
Publications (0)
Data not yet available