Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of a single intraoperative intraperitoneal application of cisplatin after neoadjuvant chemotherapy in patients with advanced (stage IIIC) epithelial ovarian cancer
Acronym
Study hypothesis
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
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
Study design
Prospective phase II trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
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 trial start date
19/02/2015
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant 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)
Recruitment start date
01/09/2015
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Slovenia
Trial participating centre
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor information
Organisation
Institute of Oncology Ljubljana
Sponsor details
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Institute of Oncology Ljubljana (Slovenia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list