Is it beneficial to give chemotherapy before surgery in patients with advanced ovarian cancer?
| ISRCTN | ISRCTN16064304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16064304 |
| Secondary identifying numbers | 201617040.3 |
- Submission date
- 29/09/2020
- Registration date
- 02/10/2020
- Last edited
- 08/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
9 Street 23
Maadi
Cairo
11728
Egypt
 ORCID ID |
0000-0003-0062-0464 |
|---|---|
| Phone | +20 1006023091 |
| tamer.manie@nci.cu.edu.eg |
Study information
| Study design | Single center observational prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Is interval debulking surgery as effective as primary debulking surgery for locally advanced epithelial ovarian cancer? |
| Study acronym | IIDSAEAPDSFLAEOC |
| Study objectives | Interval debulking surgery after neoadjuvant chemotherapy is not inferior to primary debulking surgery in locally advanced epithelial ovarian cancer |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/09/2017 |
| Completion date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 56 |
| Key inclusion criteria | Patients with locally advanced epithelial ovarian cancer |
| Key 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 |
| Date of first enrolment | 17/10/2017 |
| Date of final enrolment | 31/01/2019 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Cairo
11796
Egypt
Sponsor information
Hospital/treatment centre
National Cancer Institute
Kasr Al Eini street
Fom El Khalig
Cairo
11796
Egypt
| Phone | +20 23689711 |
|---|---|
| webmaster@nci.cu.edu.eg | |
| Website | https://nci.cu.edu.eg |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
University/education
Government organisation / National government
- Alternative name(s)
- NCI
- Location
- Egypt
Results and Publications
| Intention to publish date | 15/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/10/2020 | No | No |
Additional files
- ISRCTN16064304_PROTOCOL.docx
- Uploaded 08/10/2020
Editorial Notes
08/10/2020: Uploaded protocol (not peer reviewed).
02/10/2020: Trial’s existence confirmed by Cairo University National Cancer Institute IRB
