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Alkylating agents

HIPEC with Surgery for Ovarian Cancer (OVHIPEC-2 Trial)

Phase 3
Recruiting
Research Sponsored by The Netherlands Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for primary CRS
Histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after end of treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial

OVHIPEC-2 Trial Summary

This trial is testing whether adding hyperthermic intraperitoneal chemotherapy to primary cytoreductive surgery improves outcomes for stage III epithelial ovarian cancer.

Who is the study for?
This trial is for individuals with stage III epithelial ovarian, fallopian tube, or primary peritoneal cancer who are candidates for initial surgery to remove the tumor. They must not have had any other cancers in the past 5 years and should not have received prior treatment for their current cancer.Check my eligibility
What is being tested?
The study is testing whether adding hyperthermic intraperitoneal chemotherapy (HIPEC), which involves heating chemotherapy drugs and delivering them directly into the abdominal cavity, improves outcomes when combined with standard surgery compared to surgery alone.See study design
What are the potential side effects?
Possible side effects include those related to cisplatin such as kidney damage, hearing loss, nausea, vomiting, nerve damage leading to numbness or tingling in hands and feet, allergic reactions and an increased risk of infection.

OVHIPEC-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a candidate for major surgery to remove cancer.
Select...
My cancer is in stage III and started in the ovary, fallopian tube, or nearby areas.

OVHIPEC-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
overall survival
Secondary outcome measures
adverse events
cost evaluation
recurrence-free survival

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667
46%
Platelet count decreased
38%
Nausea
23%
Chills
23%
Vomiting
23%
Fatigue
23%
White blood cell decreased
23%
Dyspnea
15%
Urinary tract infection
15%
Creatinine increased
15%
Anemia
15%
Weight loss
15%
Investigations-other
15%
Back pain
15%
Paresthesia
15%
Epistaxis
8%
Eyelid function disorder
8%
Nail infection
8%
Infections and infestations-others
8%
Diarrhea
8%
Sinus bradycardia
8%
Non-cardiac chest pain
8%
General disorders and administration site conditions-other
8%
Bronchial infection
8%
Alkaline phosphatase increased
8%
Bone pain
8%
Peripheral sensory neuropathy
8%
Fever
8%
Upper respiratory infection
8%
Confusion
8%
Tachyarrhythmia
8%
Gastrointestinal hermorrhage
8%
Ileus
8%
General disorders-other
8%
Catheter related infection
8%
Hematuria
8%
Urinary tract obstruction
8%
Pleural effusion
8%
Vertigo
8%
Endocrine disorders-other
8%
Neutrophil count decreased
8%
Arthralgia
8%
Pain in extremity
8%
Neck pain
8%
Generalized muscle weakness
8%
Neoplasms benign, malignant and unspecified-others
8%
Depression
8%
Alopecia
8%
Nail ridging
8%
Surgical and medical procedures-others
8%
Chill
8%
Gastrointestinal hemorrhage
8%
Arthritis
8%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab/Gemcitabine/Cisplatin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

OVHIPEC-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HIPECExperimental Treatment1 Intervention
Primary cytoreductive surgery with HIPEC with cisplatin
Group II: conventional surgeryActive Control1 Intervention
Primary cytoreductive surgery without HIPEC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cisplatin
1997
Completed Phase 3
~3290

Find a Location

Who is running the clinical trial?

The Netherlands Cancer InstituteLead Sponsor
282 Previous Clinical Trials
179,418 Total Patients Enrolled
6 Trials studying Ovarian Cancer
1,762 Patients Enrolled for Ovarian Cancer

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03772028 — Phase 3
Ovarian Cancer Research Study Groups: HIPEC, conventional surgery
Ovarian Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03772028 — Phase 3
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03772028 — Phase 3

Frequently Asked Questions

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

Are there any other existing reports on cisplatin's effects?

"Cisplatin is being investigated in 714 active clinical trials, with 284 of those trials being Phase 3 trials. Though many of these trials are based in Shanghai, China, there are a total of 43119 locations worldwide conducting cisplatin trials."

Answered by AI

What are some of the short- and long-term side effects of cisplatin?

"cisplatin received a score of 3 because, as a Phase 3 trial medication, there is available data that affirms its efficacy and rounds of data attesting to its safety."

Answered by AI

What are the primary health reasons that doctors prescribe cisplatin?

"Cisplatin is an effective treatment against ovarian cancer that has progressed, testicular cancer that has progressed, and cancers that are unresponsive to standard therapies."

Answered by AI
~111 spots leftby Apr 2025