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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01833832
The ClinicalTrials.gov registry entry for NCT01833832 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01833832 reports 0 study locations.
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.
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