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New treatment option for ENSAT Stage I Adrenal Cortex Carcinoma
Official title Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
ClinicalTrials.gov ID: NCT03583710
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ensat stage i adrenal cortex carcinoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a histologically confirmed diagnosis of ACC (Weiss score of \>= 3). (LinWeiss-Bisceglia system will be used for oncocytic ACC).
- 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)...
- Have perioperative imaging (computed tomography [CT] with contrast, magnetic resonance imaging [MRI] of the chest/abdomen/pelvis, or...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Be able to comply with the protocol procedures.
You likely can't join if
- The time between primary surgery and randomization \> 90 days.
- Gross residual disease after surgery (R2 resection)
- High suspicion for metastatic disease on perioperative imaging
- They have undergone repeated surgery for recurrence of disease.
- They have a history of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal...
- They have renal insufficiency (estimated glomerular filtration rate [GFR] \< 50 mL/min/1.73 m\^2).
See the full eligibility criteria
- Have a histologically confirmed diagnosis of ACC (Weiss score of \>= 3). (LinWeiss-Bisceglia system will be used for oncocytic ACC).
- 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...
- Have perioperative imaging (computed tomography [CT] with contrast, magnetic resonance imaging [MRI] of the chest/abdomen/pelvis, or fluorodeoxyglucose positron emission tomography [FDG-PET] CT) without unequivocal...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Be able to comply with the protocol procedures.
- Provide written informed consent.
- The time between primary surgery and randomization \> 90 days.
- Gross residual disease after surgery (R2 resection)
- High suspicion for metastatic disease on perioperative imaging
- They have undergone repeated surgery for recurrence of disease.
- They have a history of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been...
- They have renal insufficiency (estimated glomerular filtration rate [GFR] \< 50 mL/min/1.73 m\^2).
- They have significant liver insufficiency (serum bilirubin \> 2 times the upper normal range)
- They have significant liver insufficiency (serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST] \> 3 times the upper normal range)
- Impaired bone marrow reserve (neutrophils \< 1000/mm\^3)
- Impaired bone marrow reserve (platelets \< 100,000/mm\^3)
- Pregnancy or breast feeding.
- They have known congestive heart failure (ejection fraction \< 45%). The extent of cardiac testing will depend on the judgment of the local principal investigator (PI). In general, in patients with a history of cardiac...
- They have preexisting grade 2 peripheral neuropathy.
- They underwent previous or current treatment with mitotane or other antineoplastic drugs for ACC.
- They underwent previous radiotherapy for ACC.
- They have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would, in the judgment of the investigator, pose excess risk associated with study participation or...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
- Angers, France
- Besançon, France
- Brest, France
- Dijon, France
- Lyon, France
- Marseille, France
- Nantes, France
- Paris, France
- Pessac, France
- Poitiers, France
- Reims, France
- Strasbourg, France
- Toulouse, France
- Villejuif, France
- Munich, Germany
- Würzburg, Germany
- Gliwice, Poland
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Houston, Texas, United States; Angers, France; Besançon, France; Brest, France and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.