Condition category
Cancer
Date applied
29/09/2020
Date assigned
02/10/2020
Last edited
08/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Ovarian cancer, or cancer of the ovaries, is one of the most common types of cancer in women.
The ovaries are a pair of small organs located low in the tummy that are connected to the womb and store a woman's supply of eggs.
Ovarian cancer mainly affects women who have been through the menopause (usually over the age of 50), but it can sometimes affect younger women.
This is a study on female patients diagnosed with advanced-stage ovarian cancer. The main aim of the study was to compare 2 different treatment strategies: Either undergo surgery first or undergo surgery after receiving chemotherapy first.

Who can participate?
Patients with locally advanced epithelial ovarian cancer

What does the study involve?
Patients who are suitable for immediate surgery have surgery to remove the tumor followed by chemotherapy for 10 weeks. Those not suitable for surgery have 10 weeks of chemotherapy followed by surgery. Follow up is for 18 months.

What are the possible benefits and risks of participating?
Possible benefits from participating include surgical excision of ovarian cancer with the intent of cure. Possible risks of participating include the occurrence of complications after surgery as bleeding and infection. The group that will receive chemotherapy first may encounter complications as nausea, vomiting and hair loss.

Where is the study run from?
The National Cancer Institute, Cairo University (Egypt)

When is the study starting and how long is it expected to run for?
September 2017 to July 2019

Who is funding the study?
The National Cancer Institute, Cairo University (Egypt)

Who is the main contact?
Dr Tamer Manie, tamer.manie@nci.cu.edu.eg

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tamer Manie

ORCID ID

http://orcid.org/0000-0003-0062-0464

Contact details

9 Street 23
Maadi
Cairo
11728
Egypt
+20 1006023091
tamer.manie@nci.cu.edu.eg

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

201617040.3

Study information

Scientific title

Is interval debulking surgery as effective as primary debulking surgery for locally advanced epithelial ovarian cancer?

Acronym

IIDSAEAPDSFLAEOC

Study hypothesis

Interval debulking surgery after neoadjuvant chemotherapy is not inferior to primary debulking surgery in locally advanced epithelial ovarian cancer

Ethics approval

Approved 17/10/2017, Cairo University National Cancer Institute IRB (Fom El Khalig, Cairo, 11796, Egypt; +(202) 25328286; irb@nci.cu.edu.eg), ref: n/a

Study design

Single center observational prospective cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Ovarian cancer

Intervention

Patients in the primary debulking surgery arm underwent surgical exploration with the intent of having no residual tumor. The surgical procedure included total abdominal hysterectomy, bilateral salpingo-ophorectomy , omentectomy, pelvic and/or para-aortic lymphadenectomy and resection of parts of adjacent organs if needed to achieve complete cytoreduction.
This was followed by 6 cycles of adjuvant chemotherapy every 3 weeks.
Patients who were not considered good surgical candidates or whose tumors were deemed irresectable received 6 cycles of neoadjuvant chemotherapy every 3 weeks followed by surgical exploration as the primary debulking surgery arm.

Total duration of treatment 10 weeks and 18 months follow up.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Retrieved from operative notes in patient medical records at the end of patient stay:
1. Operative time
2. Procedure performed
3. Need for blood transfusion
4. Post operative complications

Secondary outcome measures

Progression free survival assessed using imaging and lab tests every 6 months up to 18 months

Overall trial start date

15/09/2017

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients with locally advanced epithelial ovarian cancer

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Total final enrolment

56

Participant exclusion criteria

1. Patients with stage I and II tumors
2. Non-epithelial histology or borderline tumors
3. Underwent surgical interventions outside the trial institute

Recruitment start date

17/10/2017

Recruitment end date

31/01/2019

Locations

Countries of recruitment

Egypt

Trial participating centre

National Cancer Institute
Fom El Khalig street
Cairo
11796
Egypt

Sponsor information

Organisation

Cairo University

Sponsor details

National Cancer Institute
Kasr Al Eini street
Fom El Khalig
Cairo
11796
Egypt
+20 23689711
webmaster@nci.cu.edu.eg

Sponsor type

Hospital/treatment centre

Website

https://nci.cu.edu.eg

Funders

Funder type

University/education

Funder name

National Cancer Institute, Cairo University

Alternative name(s)

NCI

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Egypt

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

15/11/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/10/2020: Uploaded protocol (not peer reviewed). 02/10/2020: Trial’s existence confirmed by Cairo University National Cancer Institute IRB