Ovarian Epithelial CancerNCT06404671
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
A study testing Delayed interval cytoreductive surgery (DICS) and Early interval cytoreductive surgery (EICS) in people with Ovarian Epithelial Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Epithelial Cancer
- What is being tested?
- Delayed interval cytoreductive surgery (DICS) and Early interval cytoreductive surgery (EICS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 20 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Patients aged 18 to 75 years.
- International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
- Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
- ECOG performance status: 0 or 1.
- Resectable disease by laparoscopic assessment after 3 cycles of NACT.
- Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
- Estimated life expectancy of > 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.
Who cannot join
- Metastatic ovarian carcinoma.
- Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
- Presence of pregnancy or breast-feeding.
- History of other invasive malignancies in the previous 5 years.
- History of a recent < 6 month cerebrovascular accident.
- Uncontrolled systemic disease or contraindication to chemotherapy.
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- Progressive disease on NACT.
- Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
- Severe comorbidities (ACCI >= 4)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Elshatby Maternity University Hospital
Alexandria
Mervat Elsersy, PhD, +20 109 6311548, mervat.elsersy@alexmed.edu.eg
About this study
Official title: Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery
Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).
- Conditions
- Ovarian Epithelial Cancer
- Being tested
- Delayed interval cytoreductive surgery (DICS), Early interval cytoreductive surgery (EICS)
- Keywords
- high grade serous, advanced primary ovarian cancer, interval cytoreduction
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed interval cytoreductive surgery (DICS)Procedure or surgery
patients will receive six courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by delayed interval cytoreductive surgery (DICS) within 6 weeks of the last cycle of chemotherapy. After DICS, patients will be assessed for the need or not for further adjuvant chemotherapy.
chemotherapy regimen:
- Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks.
- Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks.
- Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.
Early interval cytoreductive surgery (EICS)Procedure or surgery
patients will receive three courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by early interval cytoreductive surgery (EICS) within 6 weeks of the last cycle of chemotherapy. After EICS, patients will receive adjuvant three courses of intravenous carboplatin and paclitaxel every 3 weeks, then will be assessed for the need or not for further adjuvant chemotherapy.
chemotherapy regimen:
- Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks.
- Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks.
- Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| delayed interval cytoreduction surgery (DICS) | Experimental | delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks Receives: Procedure: Delayed interval cytoreductive surgery (DICS) |
| Early interval cytoreduction surgery (EICS) | Active comparator | Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks Receives: Procedure: Early interval cytoreductive surgery (EICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS will be defined as the time to recurrence/progression, or the date of death. Disease recurrence/ progression is defined as an increase in cancer antigen 125 (CA 125) levels or evidence of recurrence by imaging and/or histology.
Measured: up to 5years
Overall survival (OS)
OS will be defined as the time until the patient's death from any cause. The time to event occurrence will be calculated from the time of randomization until the event of interest.
Measured: up to 5 years
Secondary outcomes (7)
Operative peritoneal cancer index (PCI) assessment
pre- and post-operative PCI
Measured: 3-6 months
Complete resection rate
proportion of patients without macroscopically visible disease according to residual (R), patients will have R0 if no macroscopic residual, R1 if the residual is ≤10 mm, and R2 if the residual is > 10 mm.
Measured: 3-6 months
Surgical complexity scoring (low, intermediate, or high)
assessment of complexity score of during surgery
Measured: 3-6 months
Post-operative morbidity
Post-operative morbidity according to the Clavien-Dindo classification (CDC), i.e., proportion of severe complications (CDC grade 3-5) within 30 days of surgery.
Measured: within 30 days of surgery
Pathological complete chemotherapy response score (CRS 3)
Pathological complete chemotherapy response score (CRS 3) in the pathology specimen
Measured: 3-6 months
The total number of chemotherapy cycles administered
The total number of chemotherapy cycles administered (NACT + adjuvant cycles).
Measured: 8 months
Tumour recurrence and death
Proportion of patients who had recurrence or died in each group.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Sep 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CancerStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404671
- Sponsor's protocol ID
- SGOU 1
- Status last verified
- Jan 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT06404671
- Acronym / sponsor ID
- SGOU 1
- Conditions
- Ovarian Epithelial Cancer
- Keywords
- high grade serous, advanced primary ovarian cancer, interval cytoreduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 20 Mar 2029 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed interval cytoreduction surgery (DICS) | Experimental | Procedure: Delayed interval cytoreductive surgery (DICS)delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks |
| Early interval cytoreduction surgery (EICS) | Active comparator | Procedure: Early interval cytoreductive surgery (EICS)Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female Patients aged 18 to 75 years.
- International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
- Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
- ECOG performance status: 0 or 1.
- Resectable disease by laparoscopic assessment after 3 cycles of NACT.
Key exclusion criteria (9 listed)
- Metastatic ovarian carcinoma.
- Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
- Presence of pregnancy or breast-feeding.
- History of other invasive malignancies in the previous 5 years.
- History of a recent < 6 month cerebrovascular accident.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed interval cytoreductive surgery (DICS)patients will receive six courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by delayed interval cytoreductive surgery (DICS) within 6 weeks of the last cycle of chemotherapy. After DICS, patients will be assessed for the need or not for further adjuvant chemotherapy. chemotherapy regimen: * Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks. * Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks. * Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks. | Procedure or surgery | delayed interval cytoreduction surgery (DICS) |
| Early interval cytoreductive surgery (EICS)patients will receive three courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by early interval cytoreductive surgery (EICS) within 6 weeks of the last cycle of chemotherapy. After EICS, patients will receive adjuvant three courses of intravenous carboplatin and paclitaxel every 3 weeks, then will be assessed for the need or not for further adjuvant chemotherapy. chemotherapy regimen: * Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks. * Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks. * Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks. | Procedure or surgery | Early interval cytoreduction surgery (EICS) |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 5years
PFS will be defined as the time to recurrence/progression, or the date of death. Disease recurrence/ progression is defined as an increase in cancer antigen 125 (CA 125) levels or evidence of recurrence by imaging and/or histology.
Overall survival (OS)
Time frame: up to 5 years
OS will be defined as the time until the patient's death from any cause. The time to event occurrence will be calculated from the time of randomization until the event of interest.
7 secondary outcomes
Operative peritoneal cancer index (PCI) assessment
Time frame: 3-6 months
Complete resection rate
Time frame: 3-6 months
Surgical complexity scoring (low, intermediate, or high)
Time frame: 3-6 months
Post-operative morbidity
Time frame: within 30 days of surgery
Pathological complete chemotherapy response score (CRS 3)
Time frame: 3-6 months
The total number of chemotherapy cycles administered
Time frame: 8 months
Tumour recurrence and death
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed interval cytoreductive surgery (DICS) and Early interval cytoreductive surgery (EICS) in people with Ovarian Epithelial Cancer, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayat Sharaf, MsC (00201025774942, h_mohammed14@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 5years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.