Recruiting
Phase 2

HIPEC

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05123807

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cytoreductive surgery

Study Details

Brief summary:

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

Conditions

Ovarian Cancer

Study ID

NCT05123807

Start date

Jan 7, 2022

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cytoreductive surgery

Interventions

Cytoreductive surgery

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Aaron Shafer, MD

832-885-6133AShafer@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Aaron Shafer

832-885-6133AShafer@mdanderson.org

Principal Investigator:

Aaron Shafer, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.