Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytoreductive surgery.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
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
Interventions
- Other Cytoreductive surgery
(an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy
Primary outcome measures
- 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]
Eligibility criteria
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):
- 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)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT05123807 · 2021-0660 · NCI-2021-12842