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

ISRCTN	ISRCTN14782577
DOI	https://doi.org/10.1186/ISRCTN14782577
Secondary identifying numbers	N/A

Submission date: 21/07/2015
Registration date: 14/09/2015
Last edited: 08/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Ovarian cancer is a cancer that begins in an ovary. Intraperitoneal application (injection into the body cavity) of the anti-cancer drug cisplatin prolongs the survival of patients with advanced ovarian cancer when applied after primary surgery. However, due to its side effects this treatment is rarely used. The aim of this study is to determine the effectiveness and side effects of a single intraperitoneal application of cisplatin at surgery after the completion of chemotherapy with paclitaxel and carboplatin in patients with advanced ovarian cancer.

Who can participate?
Women aged under 75 with advanced (stage IIIC) epithelial ovarian cancer.

What does the study involve?
Patients are treated with chemotherapy consisting of paclitaxel and carboplatin. After 3-6 cycles of chemotherapy patients undergo surgery. At the end of the surgery all patients will recieve a single intraperitoneal application of cisplatin. Any side effects will be recorded daily and later at follow-up visits. After 4-6 weeks the patients will be treated with a further three cycles of paclitaxel/carboplatin. Patients will then be followed up every 3 months.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Institute of Oncology Ljubljana (Solvenia).

When is the study starting and how long is it expected to run for?
February 2015 to December 2018.

Who is funding the study?
Institute of Oncology Ljubljana (Slovenia).

Who is the main contact?
Dr Erik Škof

Contact information

Dr Erik Skof
Scientific

Institute of Oncology Ljubljana
Ljubljana
1000
Slovenia

Study information

Study design	Prospective phase II trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The role of a single intraoperative intraperitoneal application of cisplatin after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer
Study objectives	Single intraoperative intraperitoneal application of cisplatin improves progression free survival (PFS) after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer.
Ethics approval(s)	1. Komisija Republike Slovenije Za Medicinsko Etiko, 16/05/2015, KME 127/04/15 2. Republic of Slovenia National Medical Ethics Committee, 16/05/2015, NMEC 127/04/15
Health condition(s) or problem(s) studied	Advanced (stage IIIC) epithelial ovarian cancer
Intervention	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).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Cisplatin
Primary outcome measure	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 measures	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.
Overall study start date	19/02/2015
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Key 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
Key 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)
Date of first enrolment	01/09/2015
Date of final enrolment	31/12/2018

Locations

Countries of recruitment

Slovenia

Study participating centre

Institute of Oncology Ljubljana

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Institute of Oncology Ljubljana
Hospital/treatment centre

Zaloska 2
Ljubljana
1000
Slovenia

Website	www.onko-i.si
"ROR"	https://ror.org/00y5zsg21

Funders

Funder type

Hospital/treatment centre

Institute of Oncology Ljubljana (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Results of this study are planned to be presented at the ESMO and/or ASCO meeting and published in the scientific literature (with SCI impact factor).
IPD sharing plan