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

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Stage III and IV Ovarian Cancer

Treatments: Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06980545

NeoPAR study

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

total neoadjuvant 6 cycles of chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)