CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01833832
NCT01833832Phase 2Completed

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

National Cancer Institute (NCI)·interventional·Posted Apr 17, 2013·Updated Jul 30, 2019

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Cytoreductive surgery, and 1 other intervention for Adrenocortical Carcinoma and Peritoneal Carcinomatosis. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2013
Enrollment StartApr 12, 2013
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.2 years ago

Interventions

Cisplatindrug

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Cytoreductive surgeryprocedure

Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

sodium thiosulfatedrug

sodium thiosulfate will be given to limit the toxicity of cisplatin