Condition category
Cancer
Date applied
21/07/2015
Date assigned
14/09/2015
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Erik Skof

ORCID ID

Contact details

Institute of Oncology Ljubljana
Ljubljana
1000
Slovenia

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 measures

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

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

www.onko-i.si

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes