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RecruitingNCT05123807Updated Oct 7, 2026

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

A Phase 2 interventional study of Cytoreductive surgery in Ovarian Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Read the detailed description

PRIMARY OBJECTIVE:

The primary objective is to estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

SECONDARY OBJECTIVES:

  • To estimate overall survival (OS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
  • To evaluate toxicity and morbidity of secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
  • To estimate quality of life after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
  • To estimate what proportion of patients who preoperatively appear to be candidates for secondary cytoreductive surgery and HIPEC are found to have unresectable disease at time of surgical exploration
  • To collect blood and tumor samples for biobanking to be used for exploratory endpoints
02

Conditions studied

  • Ovarian Cancer

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03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Cytoreductive surgery

    Other: Cytoreductive surgery

Interventions

  • OtherCytoreductive surgery

    (an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy

06

What researchers measure

Primary outcomes

  1. To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

    Time frame: through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion

07

Study locations

1 of 1 sites recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05123807
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Nov 17, 2021
Start date
Jan 7, 2022
Primary completion
Feb 2, 2027 (estimated)
Completion
Feb 2, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Aaron Shafer, MD
Contact
AShafer@mdanderson.org
832-885-6133
Aaron Shafer, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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