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NCT01833832 · ClinicalTrials.gov registry record · Phase 2
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01833832: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01833832 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01833832, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Background: \- Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed. Those whose tumors have spread inside their abdomen may have an especially poor outcome. In these cases, traditional chemotherapy is not very effective. One possible new treatment is aggressive surgery with heated chemotherapy. This type of treatment has been more effective for other types of cancer in the abdomen. Researchers want to see this if approach can improve the outcomes of people with ACC. Objectives: \- To test the safety and effectiveness of surgery and heated chemotherapy for ACC. Eligibility: \- Individuals at least 18 years of age who have advanced ACC. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. Heart function tests will be given. Imaging studies will be used to locate the surgical sites before the operation. * Participants will have surgery to remove ACC tumor tissue. After the tumors have been removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any remaining cancer cells and make them easier to destroy. It will also focus the treatment on the tumor sites, rather than the whole body. * Participants will recover in the hospital for several days after surgery. They will have regular follow-up visits to monitor the outcome of the surgery.
Primary Outcome
Amount of time subject survives without intraperitoneal disease progression after treatment. Disease progression is defined as imageable tumor nodules or increasing ascites persistent on computed tomography (CT) scan as interpreted by the official interpretation of the imaging studies.
Interventions
- DRUG Cisplatin
- PROCEDURE Cytoreductive surgery
- DRUG sodium thiosulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-04-12 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 2 |
What the finished NCT01833832 record still lists
NCT01833832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01833832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01833832 about?
NCT01833832 is a clinical study titled "Surgery and Heated Chemotherapy for Adrenocortical Carcinoma". Background: \- Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed. Those whose tumors have spread inside their abdomen may have an especially poor outcome. In these cases, traditional chemotherapy is ...
What is the current status of trial NCT01833832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2013-04-12. Estimated completion is 2018-08-09.
What interventions are being tested in trial NCT01833832?
The interventions under investigation include: Cisplatin (DRUG), Cytoreductive surgery (PROCEDURE), sodium thiosulfate (DRUG).
Who is sponsoring clinical trial NCT01833832?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01833832's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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