cisplatin for Ovarian Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ovarian Cancercisplatin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 30 days after end of treatment

Year 1
overall survival
recurrence-free survival
1 year after lplv
cost evaluation
Day 30
adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Trastuzumab/Gemcitabine/Cisplatin
46%Platelet count decreased
38%Nausea
23%White blood cell decreased
23%Chills
23%Fatigue
23%Dyspnea
23%Vomiting
15%Weight loss
15%Paresthesia
15%Creatinine increased
15%Anemia
15%Urinary tract infection
15%Back pain
15%Investigations-other
15%Epistaxis
8%Neoplasms benign, malignant and unspecified-others
8%Non-cardiac chest pain
8%Bone pain
8%Hematuria
8%Confusion
8%Depression
8%General disorders and administration site conditions-other
8%Alopecia
8%Peripheral sensory neuropathy
8%Surgical and medical procedures-others
8%Gastrointestinal hermorrhage
8%Tachyarrhythmia
8%Catheter related infection
8%Ileus
8%General disorders-other
8%Urinary tract obstruction
8%Eyelid function disorder
8%Vertigo
8%Pleural effusion
8%Endocrine disorders-other
8%Diarrhea
8%Alkaline phosphatase increased
8%Nail infection
8%Neck pain
8%Arthralgia
8%Upper respiratory infection
8%Pain in extremity
8%Infections and infestations-others
8%Neutrophil count decreased
8%Generalized muscle weakness
8%Nail ridging
8%Chill
8%Gastrointestinal hemorrhage
8%Arthritis
8%Fever
8%Sinus bradycardia
8%Bronchial infection
8%Pain
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT02006667) in the Trastuzumab/Gemcitabine/Cisplatin ARM group. Side effects include: Platelet count decreased with 46%, Nausea with 38%, White blood cell decreased with 23%, Chills with 23%, Fatigue with 23%.

Trial Design

2 Treatment Groups

conventional surgery
1 of 2
HIPEC
1 of 2

Active Control

Experimental Treatment

538 Total Participants · 2 Treatment Groups

Primary Treatment: cisplatin · No Placebo Group · Phase 3

HIPEC
Drug
Experimental Group · 1 Intervention: cisplatin · Intervention Types: Drug
conventional surgeryNoIntervention Group · 1 Intervention: conventional surgery · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after end of treatment

Who is running the clinical trial?

The Netherlands Cancer InstituteLead Sponsor
257 Previous Clinical Trials
165,773 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,149 Patients Enrolled for Ovarian Cancer

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had breast cancer and want to have a primary CRS.