RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-01-07

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05123807

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Aaron Shafer, MD

CONTACT

832-885-6133

AShafer@mdanderson.org

Principal Investigator

Aaron Shafer, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Aaron Shafer, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2022-01-07

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2022-01-07

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Ovarian Cancer