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Corticosteroid
Mitotane +/- Cisplatin and Etoposide for Adrenal Cancer
Phase 3
Recruiting
Led By Mouhammed A Habra
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a high risk of relapse defined as: Stage I-III ACC (according to the European Network for the Study of Adrenal Tumors [ENSAT] classification) within 90 days of surgical resection of primary tumor with curative intent with either microscopically complete resection (R0, defined as no evidence of microscopic residual disease according to surgical reports, histopathology, and perioperative imaging), microscopically positive margins (R1), or undetermined margins (RX, based on surgical or pathological reports without unequivocal evidence of metastasis in the perioperative imaging). Each participating center will determine the pathological stages and resection margins AND Ki67 > 10% (to be determined by an experienced pathologist in each participating center and preferably via quantitative imaging analysis)
Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of randomization up to 2 years
Awards & highlights
Study Summary
This trial is testing whether mitotane alone or mitotane with cisplatin and etoposide is better at treating patients with a high risk of adrenocortical cancer recurrence.
Who is the study for?
This trial is for adults with Stage I-III adrenocortical cancer who've had surgery to remove the tumor. They should be at high risk of the cancer returning, have a good performance status (able to carry out daily activities), and no recent other cancers or severe health issues. Pregnant or breastfeeding individuals can't join, nor those with kidney failure, heart failure, liver problems, bone marrow suppression, neuropathy, or prior ACC treatments.Check my eligibility
What is being tested?
The study compares two approaches after surgery: one group receives only mitotane (a drug that reduces cortisol production by the body) while another group gets mitotane combined with chemotherapy drugs cisplatin and etoposide. The goal is to see which method is more effective in preventing cancer recurrence.See study design
What are the potential side effects?
Mitotane can cause nausea, diarrhea, skin rash and might affect adrenal gland function. Cisplatin may lead to kidney damage, hearing loss and nerve damage. Etoposide could result in low blood cell counts increasing infection risk; hair loss; mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had adrenal cancer surgery recently and my cancer is at a high risk of coming back.
Select...
I am able to get out of my bed or chair and move around.
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My adrenal cancer has a Weiss score of 3 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of randomization up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Distant recurrence of ACC
Local recurrence of adrenocortical carcinoma (ACC)
Recurrence-free survival (RFS)
Secondary outcome measures
Overall survival (OS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (mitotane, etoposide, cisplatin)Experimental Treatment4 Interventions
Patients receive mitotane as in Arm A. Patients also receive cisplatin IV over 2 hours on day 1 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (mitotane)Experimental Treatment2 Interventions
Patients receive mitotane PO daily on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Cisplatin
2013
Completed Phase 3
~1940
Mitotane
2022
Completed Phase 3
~420
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,765 Total Patients Enrolled
Assistance Publique - Hôpitaux de ParisOTHER
3,141 Previous Clinical Trials
56,881,217 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,106 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had adrenal cancer surgery recently and my cancer is at a high risk of coming back.My platelet count is below 100,000/mm^3.There is a strong chance that the cancer has spread to other parts of the body based on imaging tests.I have had cancer before, but it's been cured or inactive for at least 2 years, except for certain skin, cervical, or breast cancers.My liver tests are not more than 3 times the normal limit.I have heart failure with an ejection fraction below 45%.My white blood cell count is low.I have had multiple surgeries for my disease coming back.I am able to get out of my bed or chair and move around.My adrenal cancer has a Weiss score of 3 or higher.My kidney function is reduced with a GFR less than 50 mL/min.It has been over 90 days since my primary surgery.My liver is not working well (high bilirubin levels).I have had radiotherapy for adrenal cortical cancer.I still have visible cancer after surgery.I have moderate numbness or pain in my hands or feet.I have been treated with mitotane or other cancer drugs for adrenal cancer.My recent scans show no clear signs of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (mitotane, etoposide, cisplatin)
- Group 2: Arm A (mitotane)
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.
For what purpose is Cisplatin commonly employed?
"In addition to being an effective treatment for neoplasm metastasis, Cisplatin can also help patients with prostate cancer, advanced testicular cancer, and small cell lung cancer (sclc)."
Answered by AI
Has Cisplatin been federally sanctioned for medicinal use?
"Cisplatin has a Power score of 3, meaning that while it is a phase 3 drug and thus hasn't been extensively studied yet, the data collected thus far supports its efficacy and safety."
Answered by AI
Could you please list any other research studies that have used Cisplatin?
"At the moment, 983 different clinical trials are underway to test Cisplatin. Of these, 352 are in Phase 3. Most of these trials are based in one city, Shanghai, but there are 51561 total locations running Cisplatin trials."
Answered by AI
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