Total Neoadjuvant 6 Cycles of Chemotherapy Versus 3 Cycles in Partial Responder Patients Diagnosed With Epithelial Ovarian Cancer

NCT06980545 | Not Yet Recruiting Phase 3

• 1 other identifier: NeoPAR study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 (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

Outcome Measures

Primary Outcomes (1)

• 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

  it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery

Study Arms (1)

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

Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Interventions

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) DRUG

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) will be given in complete six cycles

total neoadjuvant 6 cycles of chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Relapsed ovarian cancer
• patients ineligible for Platinum-based CTH
• Patient not candidate for IDS
• stage I, II OC
• Patients progressed after 3 cycles
• Patients do not tolerate CTH

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Neoadjuvant Therapy; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Ahmed Gamal

CONTACT

+201013736679; aghussain1993@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: May 20, 2025
• Study Start: June 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share