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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
Histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after end of treatment
Awards & highlights
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 belowSelect...
My cancer is in stage III and started in the ovary, fallopian tube, or nearby areas.
OVHIPEC-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after end of treatment
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 • NCT0200666746%
Platelet count decreased
38%
Nausea
23%
Fatigue
23%
Vomiting
23%
Chills
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%
Peripheral sensory neuropathy
8%
Bronchial infection
8%
Nail infection
8%
Alkaline phosphatase increased
8%
Sinus bradycardia
8%
Eyelid function disorder
8%
Bone pain
8%
Non-cardiac chest pain
8%
General disorders and administration site conditions-other
8%
Infections and infestations-others
8%
Diarrhea
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
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
291 Previous Clinical Trials
210,921 Total Patients Enrolled
6 Trials studying Ovarian Cancer
1,762 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is at the most advanced stage (stage IV).I am a candidate for major surgery to remove cancer.My cancer is in stage III and started in the ovary, fallopian tube, or nearby areas.I have received treatment for my current cancer.I have not had any other cancers in the last 5 years.It's not possible to remove all of my cancer with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: HIPEC
- Group 2: conventional surgery
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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