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Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

This study is looking at a new way to treat adrenocortical carcinoma (ACC), a rare cancer, especially when it has spread to the lining of the abdomen (peritoneal carcinomatosis). Researchers are testing if combining surgery to remove tumors (cytoreductive surgery) with heated cisplatin chemotherapy given directly into the abdomen (HIPEC) can improve outcomes. Cisplatin is a chemotherapy drug, and sodium thiosulfate is given intravenously during the procedure. You might be able to join if you have ACC that is mostly in your abdomen, can be seen on scans like CT or PET, and your doctors believe it can be safely removed. The study will measure how long people live without their cancer growing (progression-free survival) for up to 5 years. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
You would undergo cytoreductive surgery, receive cisplatin directly into your abdomen, and sodium thiosulfate intravenously. The record does not specify the number of visits or other tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to see how long they live without their cancer growing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03127774

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Active, Not Recruiting
PHASE2Ages 18–99InterventionalTreatment
Columbia University
~30 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:CisplatinSodium thiosulfateCytoreductive surgery

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival
Measured over Up to 5 years

Conditions

Adrenocortical Carcinoma
Peritoneal Carcinomatosis

Explore related trials

Adrenal Cortical CarcinomaPeritoneal Carcinomatosis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Kazuki Sugahara, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation
Disease evaluable by 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 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 (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 HIPEC for this histology.

Exclusion

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%
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
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

What this trial measures

  • Progression Free SurvivalUp to 5 years

    The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.