NCT05123807 Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
| NCT ID | NCT05123807 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-01-07 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-01-07 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
Eligibility Criteria
Inclusion 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): 1. absolute neutrophil count \>1,500/mcL 2. platelets \>100,000/mcL 3. total bilirubin ≤ 1.5 mg/dL 4. creatinine ≤ 1.5 mg/dL 5. 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) Exclusion Criteria: * 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 regulatory authority approved indication) * 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 efficacy assessment of the investigational regimen are eligible for this trial. * 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 that would limit compliance with study requirements * 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
Contact & Investigator
Aaron Shafer, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05123807 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05123807 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05123807 currently recruiting?
Yes, NCT05123807 is actively recruiting participants. Contact the research team at AShafer@mdanderson.org for enrollment information.
Where is the NCT05123807 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05123807 clinical trial?
NCT05123807 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Aaron Shafer, MD at M.D. Anderson Cancer Center. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.