Total Neoadjuvant 6 Cycles of Chemotherapy Versus 3 Cycles in Partial Responder Patients Diagnosed With Epithelial Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin).
- Who it may be relevant to
- Registry conditions: Stage III and IV Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 3 Study to Evaluate the Role of Total Neoadjuvant Chemotherapy in Partial Responders of Locally Advanced Ovarian Cancer Cancers (NeoPAR Study)
Overview
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
Interventions
- Drug Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) will be given in complete six cycles
Primary outcome measures
- event free survival [Time frame: it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06980545 · NeoPAR study