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

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

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Key information

Conditions

Stage III and IV Ovarian Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

> 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

Exclusion criteria

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

Treatment and study plan

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Drug

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

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Gamal

CONTACT

[email protected]

+201013736679

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Phase 3 Study to Evaluate the Role of Total Neoadjuvant Chemotherapy in Partial Responders of Locally Advanced Ovarian Cancer Cancers (NeoPAR Study)

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: May 20, 2025
Registry last updated: May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.