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NCT03583710 · ClinicalTrials.gov registry record · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
A Phase 3 study of ENSAT Stage I Adrenal Cortex Carcinoma and ENSAT Stage II Adrenal Cortex Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT03583710: Recruiting Phase 3 study of ENSAT Stage I Adrenal Cortex Carcinoma and ENSAT Stage II Adrenal Cortex Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03583710 is a Phase 3 study of ENSAT Stage I Adrenal Cortex Carcinoma and ENSAT Stage II Adrenal Cortex Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03583710, a Phase 3 study of ENSAT Stage I Adrenal Cortex Carcinoma and ENSAT Stage II Adrenal Cortex Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
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. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma.
Primary Outcome
Starting from the date of randomization until documentation of radiological evidence of local recurrence, radiological evidence of distant recurrence, or death from any cause (whichever occurs first), RFS will be compared using the log-rank test between the two arms.
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER Quality-of-Life Assessment
- DRUG Etoposide
- DRUG Mitotane
Study Locations (20)
Other
- Institut de Cancérologie de l'Ouest (ICO) - Angers
- CHU Angers, Hôpital Larrey - Angers
- CHU Besançon, Hôpital Jean Minjoz - Besançon
- CHU Brest, Hôpital La Cavale Blanche - Brest
- Centre Georges François Leclerc - Dijon
- HCL Hôpital Louis Pradel - Lyon
- CHU Nantes, Hôpital René et Guillaume Laënnec - Nantes
- CHU Nantes, Hôpital René et Guillaume Laënnec - Nantes
- Hôpital Cochin, AP-HP - Paris
- Hôpital Cochin, AP-HP - Paris
- CHU Bordeaux - Hôpital Haut Lévèque - Pessac
- CHU Poitiers - Poitiers
- CHU Reims - Reims
- HUS, Hôpital Hautepierre - Strasbourg
- ICANS Institut de cancérologie Strasbourg Europe - Strasbourg
- CHU Toulouse, Hôpital Larrey - Toulouse
- CHU Toulouse, Hôpital Rangueil - Toulouse
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Missouri
- Siteman Cancer Center at Washington University - St Louis
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 3 |
What NCT03583710 shows while recruiting
NCT03583710 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with ENSAT Stage I Adrenal Cortex Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.
NCT03583710 names 20 study sites across 4 states, led by Other, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT03583710 about?
NCT03583710 is a clinical study titled "Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence". 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. Antihor...
What is the current status of trial NCT03583710?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2018-08-20. Estimated completion is 2029-01-01.
What conditions does trial NCT03583710 study?
This clinical trial studies the following conditions: ENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma.
What interventions are being tested in trial NCT03583710?
The interventions under investigation include: Cisplatin (DRUG), Quality-of-Life Assessment (OTHER), Etoposide (DRUG), Mitotane (DRUG).
Who is sponsoring clinical trial NCT03583710?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03583710 being conducted?
This trial has 20 study locations across Michigan, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03583710's enrollment target sits among peer trials
240 1274th of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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