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Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Cancer Center, Korea

About this trial

Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and written informed consent,

Patients ≥18, <80 years old,

Diagnosed with histologically confirmed FIGO stage III-IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer treated with three cycles of neoadjuvant chemotherapy,

Treated with interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,

Disqualifiers

Diagnosed with non-epithelial ovarian carcinoma or borderline ovarian tumor

Patients who have not undergone neoadjuvant chemotherapy,

Interval cytoreduction with more than 2.5 mm depth of residual disease,

A life expectancy ≤3 months as clinically judged,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cisplatin

    Drug

    Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin 75mg/m2 after interval cytoreductive surgery

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: HIPECExperimental treatment 1 intervention
Group B: No HIPECNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
From randomization to the date of death from any cause, assessed up to 5 years

Secondary outcomes

1

Progression-free survival (PFS)

Time frame
From randomization to time of first progression or death from any cause, whichever came first, assessed up to 5 years
2

Cancer-specific survival

Time frame
From randomization to the date of death due to ovarian cancer, assessed up to 5 years
3

Time to first subsequent therapy (TFST)

the interval from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent regimen for each course of chemotherapy

Time frame
from the last day of the last cycle of a prior regimen of chemotherapy to the first day of the first cycle of the subsequent chemotherapy, assessed up to 5 years
4

Treatment-related adverse events

assessed by CTCAE ver.5.0

Time frame
From randomization up to the end of treatment plus 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center, Korea

Lead sponsor

Source ClinicalTrials.gov
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