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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer

Age ≥18 years

ECOG performance status ≤ 2

absolute neutrophil count >1,500/mcL

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cytoreductive surgery

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cytoreductive surgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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