Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
- 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.
Procedure: Cytoreductive surgery
Drug: sodium thiosulfate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma|
- To determine intraperitoneal progression free survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine morbidity of this procedure in this patient population [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine the impact of surgery and HIPEC on QOL [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine the impact of surgery and HIPEC on hormone excess [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Examine patterns of recurrence (local versus systemic) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Perform 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 ] [ Designated as safety issue: No ]
- Determine overall survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833832
|Contact: Marcia Mulquin, R.N.||(301) firstname.lastname@example.org|
|Contact: Jeremy L Davis, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center 866-820-4505 firstname.lastname@example.org|
|Principal Investigator:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|