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Anti-cancer agent

HIPEC during Surgery for Ovarian Cancer (HIPEC Trial)

Phase 2

Recruiting

Led By Laurel Berry, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy

Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy

Must not have

Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if it's possible to give chemotherapy directly into the abdomen during surgery, and if it has any effects on patients' health.

Who is the study for?

This trial is for adults over 18 with specific types of ovarian, fallopian tube, or peritoneal cancer. Participants must have completed certain surgeries and chemotherapy within a set timeframe, have no current evidence of disease, and meet specific health criteria like organ function. Pregnant individuals or those with recent infections, severe allergies to carboplatin, or unstable health conditions are excluded.

What is being tested?

The study tests the feasibility and impact on quality of life when administering heated chemotherapy (HIPEC) during a second look laparoscopy surgery in patients who've had prior treatment for certain cancers. The FACT-O questionnaire will assess participants' quality of life outcomes.

What are the potential side effects?

Potential side effects may include typical reactions to carboplatin such as nausea, fatigue, low blood counts leading to increased infection risk; pain or complications from surgery; and risks associated with heating the abdomen directly during HIPEC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show no signs of cancer after chemotherapy, confirmed by exams and tests.

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My surgery removed all visible cancer before starting chemotherapy.

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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 am 18 years old or older.

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My cancer is in the ovary, fallopian tube, or peritoneum and is stage I-III or IVA with complete resolution after chemotherapy.

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My blood counts and liver/kidney functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had an infection after surgery or chemotherapy that needed a longer hospital stay.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I am not eligible for this study because it is only for women.

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I have had chemotherapy for ovarian cancer after my first treatment.

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I have severe scar tissue in my abdomen from previous surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy

Secondary study objectives

Number of Reported Toxicities

Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Second Look Laparoscopy and HIPEC with CarboplatinExperimental Treatment3 Interventions

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

0 / 11Eligibility criteria met