NeoAdjuvant ChemoTherapy With KELIM Guided Interval vs. Delayed Interval Debulking Surgery

Sponsor
Aristotle University Of Thessaloniki
Study ID
NCT07382479
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS — PROCEDURE
    3 cycles of NACT with unfavorable KELIM score will receive 3 more cycles of NACT followed by DIDS
  • 3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT — PROCEDURE
    3 cycles of NACT with favorable KELIM score will undergo IDS followed by 3 cycles of NACT

Study Details

A prospective, international, multi-center, interventional trial of advanced epithelial ovarian cancer patients offered three cycles of neoadjuvant chemotherapy (NACT) and triaged with KELIM score. Patients with favorable score will undergo interval debulking surgery (IDS) followed by another 3 cycles, while those with unfavorable score will undergo another 3 cycles of NACT followed by delayed interval debulking surgery (DIDS).

Key Dates

First listed
Feb 2, 2026
Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Apr 1, 2031
Completion
Apr 1, 2034

Study Design

Enrollment
485 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM A: IDS
    3 cycles of NACT with a favorable KELIM score underwent IDS followed by 3 cycles of NACT
  • Experimental: ARM B: DIDS
    3 cycles of NACT with an unfavorable KELIM score will undergo 3 cycles of NACT followed by DIDS

Primary Outcome Measure

Overall survival (OS) [ Time Frame: After 5 years from last patient enrollment ]

Central Contacts

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