Advanced Cancerovarian cancerNCT04257786
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
A study testing 1ry cyto-reductive surgery and Neoadjuvant chemotherapy followed by surgery in people with Advanced Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- 1ry cyto-reductive surgery and Neoadjuvant chemotherapy followed by surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients diagnosed with epithelial ovarian cancer (By histopathology)
- Age ≥ 18 years old
- Advanced defined as (stage 2D or more ) by surgical staging.
- Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Chemotherapy naïve
- Informed consent
Who cannot join
- Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.
- Patients with uncontrolled infection.
- Patients with active bleeding or conditions associated with high risk of bleeding.
- contraindications for surgery
- contraindications To chemotherapy - bevacizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.
- Conditions
- Advanced Cancer
- Being tested
- 1ry cyto-reductive surgery, Neoadjuvant chemotherapy followed by surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1ry cyto-reductive surgeryProcedure or surgery
Also called 1ry surgery
1ry surgery then chemotherapy
Neoadjuvant chemotherapy followed by surgeryCombination product
Also called Neoadjuvant chemotherapy
chemotherapy then surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 1ry surgery Receives: Procedure: 1ry cyto-reductive surgery |
| Group 2 | Active comparator | Neoadjuvant Chemotherapy followed by surgery Receives: Combination Product: Neoadjuvant chemotherapy followed by surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient where complete resection of the tumor can be achieved
complete resection of the tumor
Measured: 3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali hussien ali sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257786
- Sponsor's protocol ID
- epithelial ovarian cancer
- Acronym
- ovarian cancer
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abutaleb H, Hussien A, Khalaf M, Badary DM, Ismail AM, Hassanein S, AlGizawy S, Moustafa SAM, Farghaly RMM, Abdel-Kawi AF. Primary Cytoreductive Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Patients with Advanced Primary Epithelial Ovarian Cancer in Low Resources Setting: A Randomized Clinical Trial. J Obstet Gynaecol India. 2025 Jun;75(3):199-205. doi: 10.1007/s13224-024-02061-w. Epub 2024 Nov 6.
PubMed 40584804
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT04257786
- Acronym / sponsor ID
- ovarian cancer / epithelial ovarian cancer
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Feb 2020 (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.
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: 1ry cyto-reductive surgery1ry surgery |
| Group 2 | Active comparator | Combination Product: Neoadjuvant chemotherapy followed by surgeryNeoadjuvant Chemotherapy followed by surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients diagnosed with epithelial ovarian cancer (By histopathology)
- Age ≥ 18 years old
- Advanced defined as (stage 2D or more ) by surgical staging.
- Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Chemotherapy naïve
Key exclusion criteria (5 listed)
- Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.
- Patients with uncontrolled infection.
- Patients with active bleeding or conditions associated with high risk of bleeding.
- contraindications for surgery
- contraindications To chemotherapy - bevacizumab
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 |
|---|---|---|
| 1ry cyto-reductive surgeryAlso: 1ry surgery1ry surgery then chemotherapy | Procedure or surgery | Group 1 |
| Neoadjuvant chemotherapy followed by surgeryAlso: Neoadjuvant chemotherapychemotherapy then surgery | Combination product | Group 2 |
Primary outcome
Percentage of patient where complete resection of the tumor can be achieved
Time frame: 3 month postoperative
complete resection of the tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 40584804Abutaleb H, Hussien A, Khalaf M, Badary DM, Ismail AM, Hassanein S, AlGizawy S, Moustafa SAM, Farghaly RMM, Abdel-Kawi AF. Primary Cytoreductive Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Patients with Advanced Primary Epithelial Ovarian Cancer in Low Resources Setting: A Randomized Clinical Trial. J Obstet Gynaecol India. 2025 Jun;75(3):199-205. doi: 10.1007/s13224-024-02061-w. Epub 2024 Nov 6.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1ry cyto-reductive surgery and Neoadjuvant chemotherapy followed by surgery in people with Advanced Cancer, run by Assiut 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali H Ali Sayed, M.Sc (02 01061830890, lolf372@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient where complete resection of the tumor can be achieved (time frame: 3 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257786, which also lists 1 linked publication.
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 6 Feb 2020.