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

April 13, 2026 updated by: M.D. Anderson Cancer Center
The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Aaron Shafer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cytoreductive surgery
Other: Cytoreductive surgery
(an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Aaron Shafer, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0660
  • NCI-2021-12842 (Other Identifier: NCI-CTRP Clinical Trials Gov Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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