Clinical trial · Interventional
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cytoreductive surgery | Procedure | — | UNRESOLVED |
| sodium thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytoreductive surgery followed by HIPEC
- description
- Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin
- interventionNames
- Drug: Cisplatin
- Procedure: Cytoreductive surgery
- Drug: sodium thiosulfate
Primary outcomes (1)
- measure
- Intraperitoneal Progression Free Survival (PFS)
- timeFrame
- Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA * Histologically proven Adrenocortical carcinoma (ACC) with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation * Disease evaluable by computed tomography (CT) or positron emission tomography (PET) imaging * All disease should be deemed resectable based on imaging studies e.g.: * Hepatic metastases (unilateral or bilateral less than or equal to 5 lesions, less than or equal to 15 cm total diameter) * Note: Hepatic lesions must be amenable to complete resection * Primary peritoneal metastases (small disease load less than or equal to P2 disease) without massive ascites or intestinal obstruction * Lung metastases (less than or equal to 3 unilateral/bilateral, 9 cm total diameter) * Note: lung lesions must be amenable to complete resection * Note: Patients with both pulmonary and hepatic metastases will be enrolled at the discretion of the principal investigator (PI) * Note: In situations where resection to Completeness of Cytoreduction Score (CC) 0 or 1 is uncertain, patients may undergo diagnostic laparoscopy prior to enrollment to determine feasibility of resection. * Greater than or equal to 18 years of age * Able to understand and sign the Informed Consent Document * Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 * Life expectancy of greater than three months * Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy * Hematology: * Absolute neutrophil count greater than 1500/mm\^3 without the support of Filgrastim. * Platelet count greater than 75,000/mm\^3. * Hemoglobin greater than 8.0 g/dl. * Chemistry: * Serum creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60 mL/min/1.73 m2 * serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal and a total serum bilirubin of less than 3 times the upper limit of normal, both of which define the upper limit of grade 2 treatment related toxicities. * Prothrombin time (PT) within 2 seconds of the upper limit of normal (international normalized ratio (INR) less than or equal to 1.8) * Recovered from any toxicity to grade 2 or less from all prior chemotherapy, immunotherapy or radiotherapy and be at least 30 days past the date of their last treatment with the exception of mitotane which may be continued. * Able to understand their disease and the exploratory nature of combining surgery and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for this histology. EXCLUSION CRITERIA * Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure. * History of congestive heart failure and/or an left ventricular ejection fraction (LVEF) less than 40% Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., greater than 65yo, diabetes, history of hypertension, elevated low-density lipoproteins (LDL), first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction less than 40%. \- Significant Chronic Obstructive Pulmonary Disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function test (PFTs) indicating an forced expiratory volume 1 (FEV1) less than 50% or a Carbon monoxide diffusing capacity (DLCO) less than 40% predicted for age Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is less than 50% of expected. * Grade 2 or greater neuropathy * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant. * Brain metastases or a history of brain metastases * Childs B or C cirrhosis * Evidence of severe portal hypertension by history, endoscopy, or radiologic studies Note: Any diagnosis of portal hypertension or clinical stigmata of such including but not limited to gastric or esophageal varices, umbilical vein varices or telangiectasias. * Weight less than 30 kg * Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
References
Publications (4)
- BACKGROUNDDatrice NM, Langan RC, Ripley RT, Kemp CD, Steinberg SM, Wood BJ, Libutti SK, Fojo T, Schrump DS, Avital I. Operative management for recurrent and metastatic adrenocortical carcinoma. J Surg Oncol. 2012 Jun 1;105(7):709-13. doi: 10.1002/jso.23015. Epub 2011 Dec 20. PMID 22189845
- BACKGROUNDLeboulleux S, Deandreis D, Al Ghuzlan A, Auperin A, Goere D, Dromain C, Elias D, Caillou B, Travagli JP, De Baere T, Lumbroso J, Young J, Schlumberger M, Baudin E. Adrenocortical carcinoma: is the surgical approach a risk factor of peritoneal carcinomatosis? Eur J Endocrinol. 2010 Jun;162(6):1147-53. doi: 10.1530/EJE-09-1096. Epub 2010 Mar 26. PMID 20348273
- BACKGROUNDFeldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7. doi: 10.1200/JCO.2003.04.150. PMID 14673042
- RESULTHughes MS, Lo WM, Beresnev T, Merino M, Shutack Y, Ripley RT, Hernandez JM, Davis JL. A Phase II Trial of Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Adrenocortical Carcinoma. J Surg Res. 2018 Dec;232:383-388. doi: 10.1016/j.jss.2018.06.012. PMID 30463745