Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
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|ClinicalTrials.gov Identifier: NCT01833832|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : May 24, 2018
- 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.
- To test the safety and effectiveness of surgery and heated chemotherapy for ACC.
- Individuals at least 18 years of age who have advanced ACC.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma Peritoneal Carcinomatosis||Drug: Cisplatin Procedure: Cytoreductive surgery Drug: sodium thiosulfate||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma|
|Study Start Date :||April 12, 2013|
|Estimated Primary Completion Date :||December 11, 2018|
|Estimated Study Completion Date :||May 1, 2019|
Cytoreductive surgery followed by HIPEC with cisplatin
Patients who are successfully debulked will then undergo HIPEC with cisplatin.
Procedure: Cytoreductive surgery
Patients will undergo cytoreductive surgery to achieve a CC of 0 or 1.
Drug: sodium thiosulfate
sodium thiosulfate will be given to limit the toxicity of cisplatin
- Median amount of time subject survives without intraperitoneal disease progression after treatment [ Time Frame: at progression ]
- Determine morbidity of this procedure in this patient population [ Time Frame: 5 years ]
- Median amount of time subject survives after therapy [ Time Frame: death ]
- Molecular analyses to try to discern if there are intrinsic differences between tumors that recur widely throughout the peritoneal surface and those that metastasize to other organs or are confined to a local recurrence. [ Time Frame: 5 years ]
- Patterns of recurrence (local versus systemic) [ Time Frame: 5 years ]
- hormone levels before and after treatment [ Time Frame: 5 years ]
- Proportion of patients that have improvement in quality of life after treatment [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833832
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|