Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer (NCT02681432) | Clinical Trial Compass
UnknownPhase 3
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer
Spain60 participantsStarted 2012-01
Plain-language summary
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
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:
* Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
* Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
* No extra-abdominal tumor disease
* Absence of heart failure. Adequate renal and hepatic functions
* Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Exclusion Criteria:
* Patients with unresectable tumor or incomplete cytoreduction.
* Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
* Extra-abdominal metastases or unresectable liver metastases
* Presence of other malignant tumor disease.
* Multisegmental complete bowel obstruction.
* Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
* Patients who refuse treatment or consent to participate in study
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.
1This trial uses a procedure called HIPEC — where heated chemotherapy is delivered directly into the abdomen during surgery — combined with paclitaxel specifically for ovarian cancer. Can you explain how this approach might compare to my current treatment plan, and whether it's something worth considering in my situation?
2Since this is a Phase 3 trial measuring overall survival, what does that mean about what researchers still don't know about how well or how safely this procedure works compared to standard treatment?
3HIPEC involves a major surgical procedure combined with chemotherapy delivered directly into the abdomen, which sounds quite intensive. Based on my overall health and how far my cancer has progressed, do you think I could physically tolerate this kind of treatment?
4The recruitment status for this trial is listed as unknown, which may mean it's no longer actively enrolling. Do you know whether this trial is still open at any center, or whether a similar HIPEC study might be available to me?
5If I were to pursue a HIPEC procedure through this or a similar trial, how would that affect my options for standard chemotherapy or other treatments afterward if it didn't work as hoped?
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.