NCT05123807

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
9mo left

Started Jan 2022

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2022Feb 2027

First Submitted

Initial submission to the registry

November 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

November 8, 2021

Last Update Submit

April 13, 2026

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

Cytoreductive surgery

OTHER
Other: Cytoreductive surgery

Interventions

Cytoreductive surgeryOTHER

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

Cytoreductive surgery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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
  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Aaron Shafer, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Shafer, MD

CONTACT

832-885-6133AShafer@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 17, 2021

Study Start

January 7, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

US(1)