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

NCT ID: NCT06980545

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-05-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

total neoadjuvant 6 cycles of chemotherapy

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

Group Type: EXPERIMENTAL

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Intervention Type: DRUG

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

Interventions

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed gamal hussein

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Gamal

Role: CONTACT

aghussain1993@gmail.com

+201013736679

Other Identifiers

NeoPAR study

Identifier Type: -

Identifier Source: org_study_id