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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN14782577
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Institute of Oncology Ljubljana
• Public title: The role of an intraoperative intraperitoneal chemotherapy after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer
• Scientific title: The role of a single intraoperative intraperitoneal application of cisplatin after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer
• Date of first enrolment: 01/09/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14782577
• Study type: Interventional
• Study design: Prospective phase II trial (Treatment)
• Phase: Phase II

Countries of recruitment

Slovenia

Contacts

• Name: Erik Skof

Key inclusion & exclusion 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: 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)

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 will undergo surgery (aim is maximal debulking). At the end of surgery all eligible patients will recieve a single intraperitoneal infusion of cisplatin 75 mg/m2. Potential toxicity of intraperitoneal chemotherapy will be recorded daily and later at follow-up visits. Later (after 4-6 weeks) postoperative (adjuvant) i.v. chemotherapy (3 cycles of paklitaxel/karboplatin) is planned. Thereafter patients will be followed up every 3 months (gin. exam, Ca 125, US/CT at suspected relapse).

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Institute of Oncology Ljubljana (Slovenia)