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Alkylating agents

HIPEC + Surgery for Ovarian Cancer (CRS/HIPEC Trial)

Phase 2
Waitlist Available
Led By Teresa Diaz-Montes, M.D.
Research Sponsored by Mercy Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage III/IV disease
Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Awards & highlights

CRS/HIPEC Trial Summary

This trial is testing whether a surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment, is a safe and effective treatment for ovarian, fallopian tube, and primary peritoneal cancer.

Who is the study for?
This trial is for adults with advanced stage (III/IV) ovarian, fallopian tube, or primary peritoneal cancer who haven't had treatment yet. They should be physically able to handle the procedures and have good organ function. Pregnant women, those with certain heart conditions, prior strokes or other cancers in the last 3 years are excluded.Check my eligibility
What is being tested?
The study tests how safe and effective it is to combine cytoreductive surgery (CRS) with heated chemotherapy directly in the abdomen (HIPEC), followed by standard chemo. It's a phase II trial where patients are randomly assigned to treatments at a community hospital.See study design
What are the potential side effects?
Possible side effects include reactions from chemotherapy like nausea, fatigue, hair loss; surgical complications; kidney issues due to medication toxicity; and increased risk of infection.

CRS/HIPEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is in stage III or IV.
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I am mostly self-sufficient and can carry out daily activities.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My kidney function is within the normal range.
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After surgery to remove as much cancer as possible, less than 1 cm of cancer remains.
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My cancer originates from the ovary, fallopian tube, or peritoneum.
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My liver tests are within the required range.

CRS/HIPEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative complication rates
Secondary outcome measures
Assessment of quality of life
Evaluate overall survival
Evaluate the rate of progression free survival
Other outcome measures
Risk factors for morbidity and mortality

CRS/HIPEC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CRS/HIPEC with adjuvant IV chemotherapyExperimental Treatment6 Interventions
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
Group II: CRS with adjuvant IV/IP chemotherapyActive Control5 Interventions
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Cytoreductive Surgery (CRS)
2015
Completed Phase 2
~20
Adjuvant Chemotherapy
2015
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Mercy Medical CenterLead Sponsor
20 Previous Clinical Trials
4,190 Total Patients Enrolled
1 Trials studying Ovarian Cancer
438 Patients Enrolled for Ovarian Cancer
Teresa Diaz-Montes, M.D.Principal InvestigatorMercy Medical Center
Armando Sardi, M.D.Principal InvestigatorMercy Medical Center
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02124421 — Phase 2
Ovarian Cancer Research Study Groups: CRS with adjuvant IV/IP chemotherapy, CRS/HIPEC with adjuvant IV chemotherapy
Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02124421 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02124421 — Phase 2
~7 spots leftby Aug 2027