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
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
- ISRCTN16064304_PROTOCOL.docx Uploaded 08/10/2020