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

Phase 2

Completed

• Conditions: Advanced (stage IIIC) epithelial ovarian cancer; Cancer; Malignant neoplasm of ovary

• Registration Number: ISRCTN14782577
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified