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

Phase 3

Not yet recruiting

• Conditions: Stage III and IV Ovarian Cancer
• Interventions: Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

• Registration Number: NCT06980545
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-15
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-30
• Primary Completion: 2026-04-30
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. > 18 years of age
2. Recently diagnosed with stage III and IV OC
3. Patients eligible for Platinum-based CTH
4. Patients have PR or SD after 3-4 cycles of NACT

Exclusion Criteria

1. Relapsed ovarian cancer
2. patients ineligible for Platinum-based CTH
3. Patient not candidate for IDS
4. stage I, II OC
5. Patients progressed after 3 cycles

7-Patients do not tolerate CTH

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
total neoadjuvant 6 cycles of chemotherapy	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

Primary Outcome Measures

Name	Time	Method
event free survival	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