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Alkylating agents

Surgery + HIPEC for Ovarian Cancer

Phase 2
Recruiting
Led By Michael Frumovitz, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 2
Patients must be > 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires >6 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion
Awards & highlights

Study Summary

This trial is testing a treatment for women with a certain type of ovarian cancer that has come back. The treatment is surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment.

Who is the study for?
This trial is for women over 18 with recurrent primary mucinous ovarian cancer. They must have good organ and marrow function, be at least two weeks out from prior chemo or radiation (six weeks for bevacizumab), not pregnant or nursing, no history of HIPEC or intraperitoneal chemotherapy, and able to sign consent.Check my eligibility
What is being tested?
The study tests the effectiveness of secondary cytoreductive surgery combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in improving overall survival rates for women with this specific type of recurrent ovarian cancer.See study design
What are the potential side effects?
Potential side effects may include complications from surgery, reactions to chemotherapy such as nausea and fatigue, risk of infection due to low blood counts, liver or kidney issues indicated by changes in blood tests, and possible hearing impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I finished my last chemotherapy or radiation more than 2 weeks ago, except for bevacizumab which was over 6 weeks ago.
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My organs and bone marrow are functioning well, as tested within the last 30 days.
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I am 18 years old or older.
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My ovarian cancer, which has come back, is confirmed to be mucinous.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Side effects data

From 2008 Phase 3 trial • 30 Patients • NCT00052962
8%
Fistula intestinal
8%
ALT/AST
8%
UTI: pyelonephritis
8%
Pleural effusion post op
8%
SVT
8%
Wound infection (superficial)
8%
AST
8%
Pleural effusion/non-malignant
8%
Post-op ileus
8%
UTI
8%
Lipase gr
8%
Ileus, wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 Surgery + Post op Chemotherapy
Arm 2 Surgery + CHPP

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cytoreductive surgeryExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,335 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,715 Patients Enrolled for Ovarian Cancer
Michael Frumovitz, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
180 Total Patients Enrolled

Media Library

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05123807 — Phase 2
Ovarian Cancer Research Study Groups: Cytoreductive surgery
Ovarian Cancer Clinical Trial 2023: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Highlights & Side Effects. Trial Name: NCT05123807 — Phase 2
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123807 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this research program?

"Accurate. Clinicaltrials.gov verifies that 30 participants are actively being sought for this trial, which was first published on January 7th 2022 and updated most recently July 28th of the same year. There is one site requiring recruitment efforts."

Answered by AI

Are there any vacancies still available for potential participants of this research study?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is actively seeking participants and was initially posted on July 1st 2022 with the latest update occuring in late July. A total of 30 patients will be enrolled at one centre."

Answered by AI

Are there any risks associated with this therapeutic intervention?

"A rating of 2 has been assigned to this therapeutic intervention, as it is currently at the Phase 2 stage. This suggests that there are some safety data available, but no efficacy data has yet been documented."

Answered by AI
~17 spots leftby Feb 2027