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New treatment option for Ovarian Cancer
Official title Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
ClinicalTrials.gov ID: NCT05123807
What this study is testing
- What it's testing
- The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
- Age ≥18 years
- ECOG performance status ≤ 2
- Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
- absolute neutrophil count \>1,500/mcL
You likely can't join if
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational...
- Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
- Patients with known active CNS metastases
- Patients with known hypersensitivity to any of the components of cisplatin
- Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or how well...
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
- Age ≥18 years
- ECOG performance status ≤ 2
- Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
- absolute neutrophil count \>1,500/mcL
- platelets \>100,000/mcL
- total bilirubin ≤ 1.5 mg/dL
- creatinine ≤ 1.5 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
- Patients must be \> 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires \>6 weeks
- Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no...
- Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
- Patients with known active CNS metastases
- Patients with known hypersensitivity to any of the components of cisplatin
- Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Women who are pregnant or nursing women
- Patients with peripheral neuropathy ≥ grade 2
- History of allogenic transplant
- History of prior HIPEC or intraperitoneal chemotherapy
- Known bulky extra-abdominopelvic disease
- Patients with hearing impairment/tinnitus ≥ grade 2
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.