The role of an intraoperative intraperitoneal chemotherapy after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer

The role of a single intraoperative intraperitoneal application of cisplatin after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14782577

Enrollment

100

Registered

2015-09-14

Start date

2015-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced (stage IIIC) epithelial ovarian cancer Cancer Malignant neoplasm of ovary

Interventions

Patients will start with neoadjuvant chemotherapy (consisting of paclitaxel 175mg/m2 3h i.v. infusion and carboplatin AUC 6 1h i.v. infusion). After 3-6 cycles of neoadjuvant chemotherapy patients wi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age <75 years 2. PS 0-1 (WHO) 3. Histology of epithelial ovarian, fallopian tube or primary peritoneal serous cancer 4. Stage IIIC primary inoperable disease 5. Completed neoadjuvant chemotherapy with paclitaxel/carboplatin (min 3 - max 6 cycles) 6. Operable disease after neoadjuvant chemotherapy 7. Normal blood count, kidney and liver biochemistry 8. Surgery planned 4-6 weeks after completion of neoadjuvant chemotherapy 9. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. No histology sample available 2. Not proven origin in ovaries, fallopian tubes or peritoneum 3. Stage other than IIIC 4. Primary operable disease 5. No prior neoadjuvant chemotherapy with paclitaxel/carboplatin combination 6. PS 2 or higher (WHO) 7. Progression of disease during neoadjuvant chemotherapy 8. Participation in other study 9. Other prior cancers (except planocelular skin cancer, cervical cancer in situ or breast cancer <5 years after end of treatment)

Design outcomes

Secondary

Measure	Time frame
1. Overall survival (OS), estimated using the Kaplan–Meyer method. 2. R0 resection rate (no macroscopic residual disease), provided by surgeon and pathologist reports. Outcomes will be recorded daily after surgery and chemotherapy, and at follow-up every 3 months.	—

Primary

Measure	Time frame
1. Toxicity (side effects of chemotherapy and of surgery), determined and scored by CTCAE criteria v. 3.0 (renal function, neuropathy, death, etc). 2. Progression-free survival (PFS), estimated using the Kaplan–Meyer method. Outcomes will be recorded daily after surgery and chemotherapy, and at follow-up every 3 months.	—

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026