BridgeMD
New treatment option for Ovarian Cancer
Official title Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04)
ClinicalTrials.gov ID: NCT05827523
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary stage III-IV epithelial ovarian cancer randomizing between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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 interval complete cytoreduction, or cytoreduction with no more than 2.5 mm depth of residual disease,
- A life expectancy \> 3 months as clinically judged,
You likely can't join if
- 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,
- History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma...
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
See the full eligibility criteria
- 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,
- A life expectancy \> 3 months as clinically judged,
- Adequate organ function for cytoreductive surgery and HIPEC,
- Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment and,
- Patients can also consent to the provision of clinical information for secondary use, such as future biomedical research. However, in the future, people can participate in the main trial even if they do not intend to...
- 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,
- History of previous malignancy within five years prior to inclusion, that affects ovarian cancer treatment results, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the...
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML,
- Patients with active central nervous system metastasis and carcinoma meningitis or patients who have been previously treated for brain metastases must be in a stable state in radiology,
- Patients with antibacterial, antifungal, or antiviral infections requiring systemic treatment (administration of parenteral antibiotics),
- Active tuberculosis that is not controlled within 1 month of treatment,
- Patients diagnosed with a psychiatric disorder or substance abuse disorder that would interfere with your ability to cooperate with the trial,
- Patients with any contraindications to the use of cisplatin (i.e., hypersensitivity to cisplatin),
- Patients with a history of allogeneic tissue/solid organ transplantation or bone marrow transplantation or a history of double umbilical cord transplantation or,
- History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results of the study, or interfere with the patient's participation, in the opinion of the treating investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Sejong, Chungcheongnam-do, South Korea
- Goyang-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Pusan, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sejong, Chungcheongnam-do, South Korea; Goyang-si, Gyeonggi-do, South Korea; Suwon, Gyeonggi-do, South Korea; Pusan, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.