Stage III and IV Ovarian CancerPhase 3NCT06980545
Total Neoadjuvant 6 Cycles of Chemotherapy Versus 3 Cycles in Partial Responder Patients Diagnosed With Epithelial Ovarian Cancer
A Phase 3 study testing Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) in people with Stage III and IV Ovarian Cancer, run by Assiut University.
Trial summary
neoadjuvant chemotherapy in stage III and IV ovarian cancer is given in 3-4 cycles with patients who R0 surgical resection is less likely to occur, in this study will assess total neoadjuvant chemotherapy 6 cycles then interval debulking surgery (experimental arm) versus 4 cycles then interval debulking surgery… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage III and IV Ovarian Cancer
- What is being tested?
- Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 30 May 2028
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Recently diagnosed with stage III and IV OC
- Patients eligible for Platinum-based CTH
- Patients have PR or SD after 3-4 cycles of NACT
Who cannot join
- Relapsed ovarian cancer
- patients ineligible for Platinum-based CTH
- Patient not candidate for IDS
- stage I, II OC
- Patients progressed after 3 cycles
- 7-Patients do not tolerate CTH
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 3 Study to Evaluate the Role of Total Neoadjuvant Chemotherapy in Partial Responders of Locally Advanced Ovarian Cancer Cancers (NeoPAR Study)
neoadjuvant chemotherapy in stage III and IV ovarian cancer is given in 3-4 cycles with patients who R0 surgical resection is less likely to occur, in this study will assess total neoadjuvant chemotherapy 6 cycles then interval debulking surgery (experimental arm) versus 4 cycles then interval debulking surgery (control arm) in patients who achieve partial response or stationary disease by imaging after 3- 4 cycles of neoadjuvant chemotherapy, investigators'' primary end points will be event free survival, safety and tolerability and time to relapse, our secondary end points will be overall survival and surgical morbidity and mortality
- Conditions
- Stage III and IV Ovarian Cancer
- Being tested
- Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)Drug
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) will be given in complete six cycles
| Study group | Role | What they receive |
|---|---|---|
| total neoadjuvant 6 cycles of chemotherapy | Experimental | patients who have stationary disease or partial response by MRI after 3 cycles, investigators will give another 3 cycles of chemotherapy to complete six cycles Receives: Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery
Measured: it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III and IV Ovarian 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed gamal hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980545
- Sponsor's protocol ID
- NeoPAR study
- Status last verified
- May 2025
- First submitted
- 15 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate the Role of Total Neoadjuvant Chemotherapy in Partial Responders of Locally Advanced Ovarian Cancer Cancers (NeoPAR Study)
- ClinicalTrials.gov ID
- NCT06980545
- Acronym / sponsor ID
- NeoPAR study
- Conditions
- Stage III and IV Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 20 May 2025 (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.
neoadjuvant chemotherapy in stage III and IV ovarian cancer is given in 3-4 cycles with patients who R0 surgical resection is less likely to occur, in this study will assess total neoadjuvant chemotherapy 6 cycles then interval debulking surgery (experimental arm) versus 4 cycles then interval debulking surgery (control arm) in patients who achieve partial response or stationary disease by imaging after 3- 4 cycles of neoadjuvant chemotherapy, investigators'' primary end points will be event free survival, safety and tolerability and time to relapse, our secondary end points will be overall survival and surgical morbidity and mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total neoadjuvant 6 cycles of chemotherapy | Experimental | Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)patients who have stationary disease or partial response by MRI after 3 cycles, investigators will give another 3 cycles of chemotherapy to complete six cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age
- Recently diagnosed with stage III and IV OC
- Patients eligible for Platinum-based CTH
- Patients have PR or SD after 3-4 cycles of NACT
Key exclusion criteria (6 listed)
- Relapsed ovarian cancer
- patients ineligible for Platinum-based CTH
- Patient not candidate for IDS
- stage I, II OC
- Patients progressed after 3 cycles
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 |
|---|---|---|
| Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) will be given in complete six cycles | Drug | total neoadjuvant 6 cycles of chemotherapy |
Primary outcome
event free survival
Time frame: it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery
the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery
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 20 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) in people with Stage III and IV Ovarian Cancer, run by Assiut University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed Gamal (+201013736679, aghussain1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival (time frame: it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery). 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 20 May 2025.