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Alkylating agents

Hyperthermic Chemotherapy for Ovarian Cancer

Phase 2

Waitlist Available

Led By Michael Kelly

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 have received at least 3 but not more than 6 cycles of carboplatin-doublet based IV neoadjuvant chemotherapy and achieved at least stable disease (radiographically confirmed) at the conclusion of this therapy.

Age ≥ 18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial will study how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer.

Who is the study for?

This trial is for women over 18 with stage IIIC-IV non-mucinous ovarian, fallopian tube, or peritoneal cancer. They must have had 3-6 cycles of specific chemo and not be treated for another cancer in the last 3 years. Good organ function and no severe illnesses are required. Participants must not be pregnant, breastfeeding, or planning to conceive.Check my eligibility

What is being tested?

The study tests hyperthermic intraperitoneal chemotherapy (heated chemo delivered directly into the abdomen) after surgery to see if it improves life quality compared to standard treatment. It's for patients who've seen stable disease after initial chemo.See study design

What are the potential side effects?

Possible side effects include typical reactions to carboplatin such as nausea, fatigue, low blood counts leading to infection risk, allergic reactions and potential harm to an unborn child; hence pregnancy is prohibited during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I've had 3-6 rounds of specific chemo for my cancer and it hasn't gotten worse.

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I am 18 years old or older.

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My cancer is a non-mucinous type and affects my ovary, fallopian tube, or peritoneum at stage 3 or 4.

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I can take care of myself but might not be able to do heavy physical work.

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Your blood cell counts, liver and kidney function need to be at certain levels within the past 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian questionnaire

Secondary outcome measures

Abdominal discomfort assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort questionnaire

Incidence of toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Neurotoxicity assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment - Carboplatin, CRS, HIPECExperimental Treatment4 Interventions

Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytoreductive Surgery

2011

Completed Phase 1

~150

Carboplatin

2014

Completed Phase 3

~6670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,240 Previous Clinical Trials

1,004,157 Total Patients Enrolled

5 Trials studying Ovarian Cancer

191 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,617 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

Michael KellyPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03188432 — Phase 2

Ovarian Cancer Research Study Groups: Treatment - Carboplatin, CRS, HIPEC

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03188432 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03188432 — Phase 2

Frequently Asked Questions

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

Could you tell me how many people are included in this experiment?

"According to the information available on clinicaltrials.gov, this study is currently looking for participants. The trial was initially posted on 10/13/2017 and was most recently edited on 8/4/2022. The clinical trial is searching for 40 patients at 1 sites."

Answered by AI

What do medical professionals most commonly use Quality-of-Life Assessments for?

"Quality-of-Life Assessment is a standard course of treatment for conditions like lymphoma and non-hodgkin. It can also help patients that are suffering from advanced sarcoma, initial treatment, hodgkin disease."

Answered by AI

Are there still opportunities for people to participate in this research?

"Yes, that is right. As of 8/4/2022, this clinical trial was still recruiting patients according to the website clinicaltrials.gov. This study was first posted on 10/13/2017."

Answered by AI

What are some risks associated with Quality-of-Life Assessment?

"Quality-of-Life Assessment scored a 2 on our team's safety scale because there is only preliminary data supporting its safety and no efficacy data as of yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2017. "Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03188432.

All > Peritoneal Carcinomatosis > Ovarian Cancer