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Alkylating agents
HIPEC for Adrenocortical Cancer
Phase 2
Recruiting
Led By Michael Kluger, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hematology: Absolute neutrophil count greater than 1500/mm^3 without the support of Filgrastim
Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
Must not have
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function test (PFT) indicating an forced expiratory volume at one second (FEV1) less than 50% or a diffusing capacity of lung for carbon monoxide (DLCO) less than 40% predicted for age
Grade 2 or greater neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at the effectiveness of surgery and chemotherapy in treating patients with adrenocortical cancer that has spread to the abdomen.
Who is the study for?
This trial is for adults with Adrenocortical Carcinoma (ACC) where the majority of cancer is in the peritoneal cavity and can be surgically removed or treated with radiofrequency ablation. Participants must have a life expectancy over three months, practice birth control, and have adequate organ function. Excluded are those with severe heart, lung conditions, active infections, significant neuropathy, brain metastases or pregnant/breastfeeding women.
What is being tested?
The study tests if surgery followed by Heated Intraperitoneal Chemotherapy (HIPEC) using cisplatin improves survival without cancer spreading inside the abdomen. It also examines side effects, quality of life changes post-treatment and whether cancer comes back locally or spreads elsewhere.
What are the potential side effects?
Potential side effects include complications from major surgery and chemotherapy such as infection risk increase, bleeding issues due to low platelet counts, kidney damage indicated by elevated creatinine levels or reduced clearance rate; liver problems shown by high AST/ALT levels; blood clotting difficulties seen in abnormal prothrombin time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication.
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I can perform daily activities with minimal assistance.
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My scans show that my cancer can be surgically removed.
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I am 18 years old or older.
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My disease can be seen on a CT or PET scan.
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My cancer is mainly in the belly area and can be surgically removed or treated with a special procedure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe lung disease with very low lung function test results.
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I have moderate to severe nerve pain or damage.
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I do not have major illnesses like heart disease, severe infections, or blood clotting disorders.
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I weigh less than 30 kg.
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My liver disease is at a moderate to severe stage.
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I have a history of heart failure or my heart pumps less effectively.
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I have or had brain metastases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival
Secondary study objectives
Morbidity Rate
Overall Survival
Quality of Life (QOL) Score
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Surgery with HIPECExperimental Treatment3 Interventions
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoreductive surgery
2013
Completed Phase 3
~180
Sodium thiosulfate
2009
Completed Phase 2
~50
Cisplatin
2013
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,237 Total Patients Enrolled
Michael Kluger, MD4.930 ReviewsPrincipal Investigator - Columbia University
Columbia University
5Patient Review
Dr. Kluger was excellent. He was very informative and easy to talk to. I feel confident in his abilities and would recommend him to others.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe lung disease with very low lung function test results.I have moderate to severe nerve pain or damage.I do not have major illnesses like heart disease, severe infections, or blood clotting disorders.My white blood cell count is healthy without needing medication.Your platelet count is higher than 75,000 per cubic millimeter.I understand my disease and the experimental treatment combining surgery and HIPEC.Your hemoglobin level is higher than 8.0 grams per deciliter.Your liver blood test results should not show very high levels of AST and ALT, and your total bilirubin should not be too high.I have recovered from previous cancer treatments with minimal side effects.I agree to use birth control during and for four months after chemotherapy.I weigh less than 30 kg.My liver disease is at a moderate to severe stage.You are expected to live for more than three months.Your blood takes a normal amount of time to clot.I can perform daily activities with minimal assistance.I have health issues that make surgery too risky for me.I have a history of heart failure or my heart pumps less effectively.I have or had brain metastases.My scans show that my cancer can be surgically removed.I am 18 years old or older.My disease can be seen on a CT or PET scan.You have severe portal hypertension, which is a condition that affects blood flow in the liver.My cancer is mainly in the belly area and can be surgically removed or treated with a special procedure.My kidney function is normal, with creatinine levels at or below 1.5 mg/dl or clearance above 60 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery with HIPEC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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