CompletedPhase 2

Short-course HIPEC in Advanced Epithelial Ovarian Cancer

15 participantsStarted 2015-02

Plain-language summary

This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion Criteria: * Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma; * Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis; * No other malignancies in activity; * No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery; * Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding; * Aged between 18 and 70 years; * Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale; * Appropriated cardio-respiratory, hepato-renal and hematological reserves; * Signing of the Consent Form. * Exclusion Criteria: * Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC; * Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3); * Limiting obesity for CRS or HIPEC; * Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PD9

Timeframe: 9 months

Trial details

NCT IDNCT02249013

SponsorProfessor Fernando Figueira Integral Medicine Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-23

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