Adrenocortical CarcinomaPhase 2NCT03127774
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
A Phase 2 study testing Cisplatin, Sodium thiosulfate and Cytoreductive surgery in people with Adrenocortical Carcinoma and Peritoneal Carcinomatosis, run by Columbia University at 1 site in United States.
Trial summary
Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adrenocortical Carcinoma, Peritoneal Carcinomatosis
- What is being tested?
- Cisplatin, Sodium thiosulfate and Cytoreductive surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 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 (PFT) indicating an forced expiratory volume at one second (FEV1) less than 50% or a diffusing capacity of lung for carbon monoxide (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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032-3729
About this study
Official title: Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used. This would be the standard of care alternative treatment.
Cisplatin is one of the most effective chemotherapeutic agents for ACC. Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin have been conducted in other tumors that spread primarily to the peritoneal lining of the abdomen. Synergy has been demonstrated for cisplatin and hyperthermia. The purpose of this trial is to determine if a surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.
Read the detailed description
Adrenocortical carcinoma (ACC) is an exceptionally rare tumor with a very poor prognosis. The best treatment of these tumors is surgical resection, and repeat operations if the tumors recur. For tumors that cannot be resected, a few drugs given intravenously exist to help slow the progression of the disease. Cisplatin given intravenously is among the most effective drugs for ACC. In studies of other tumor types, heated Cisplatin administered directly into the abdomen at the time of surgery to remove all visible tumor deposits has been shown to effectively treat the tumor over surgery alone or drugs being given intravenously. The purpose of this study is to better understand if surgical resection of all visible disease with intraperitoneal administration of heated cisplatin can improve outcomes from metastatic ACC. Additionally, the investigators would like to understand associated complications, how quality of life is affected, and if there are specific tumor factors that affect survival and recurrence after this procedure. To be eligible for the study, participants must have ACC that can be seen on CT imaging. A surgeon must believe the disease can be safely removed, and that the patient can tolerate the operation and potential complications. Patients who are successfully debulked of visible tumor will undergo heated intra-abdominal chemotherapy with Cisplatin at the same operation. Associate investigators in coordination with the Principal Investigator will evaluate patients over 18 years of age for eligibility. This investigation aims to improve quality and length of life in patients with limited options for the treatment of metastatic ACC.
- Being tested
- Cisplatin, Sodium thiosulfate, Cytoreductive surgery
- Keywords
- Cisplatin, Heated Cisplatin
- Medical subject headings
- Adrenocortical Carcinoma, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol
Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2
Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)
Sodium thiosulfateDrug
Also called Sodium thiosulfate injection
Route of administration: Intravenous Loading dose of 7.5 gm/m2 over 20 minutes followed by 2.13 gm/m2/hr for 12 hours
Drug 2 given intravenously during hyperthermic intraperitoneal chemotherapy (HIPEC)
Cytoreductive surgeryProcedure or surgery
Also called Cytoreductive debulking surgery
Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with HIPEC | Experimental | Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate Receives: Drug: Cisplatin; Drug: Sodium thiosulfate; Procedure: Cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.
Measured: Up to 5 years
Secondary outcomes (3)
Morbidity Rate
The frequency of post-operative complications.
Measured: Up to 5 years
Quality of Life (QOL) Score
This measures the impact of surgery and HIPEC on quality of life.
Measured: Up to 5 years
Overall Survival
The length of time people are alive after surgery and HIPEC for adrenocortical cancer.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start22 Sep 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who are successfully debulked will undergo heated intraperitoneal chemotherapy with cisplatin.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuki Sugahara, Columbia University
- Investigators
- Kazuki Sugahara, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127774
- Sponsor's protocol ID
- AAAQ9194
- Status last verified
- May 2026
- First submitted
- 2 Apr 2017
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
- ClinicalTrials.gov ID
- NCT03127774
- Acronym / sponsor ID
- AAAQ9194
- Keywords
- Cisplatin, Heated Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used. This would be the standard of care alternative treatment.
Cisplatin is one of the most effective chemotherapeutic agents for ACC. Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin have been conducted in other tumors that spread primarily to the peritoneal lining of the abdomen. Synergy has been demonstrated for cisplatin and hyperthermia. The purpose of this trial is to determine if a surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.
Detailed description
Adrenocortical carcinoma (ACC) is an exceptionally rare tumor with a very poor prognosis. The best treatment of these tumors is surgical resection, and repeat operations if the tumors recur. For tumors that cannot be resected, a few drugs given intravenously exist to help slow the progression of the disease. Cisplatin given intravenously is among the most effective drugs for ACC. In studies of other tumor types, heated Cisplatin administered directly into the abdomen at the time of surgery to remove all visible tumor deposits has been shown to effectively treat the tumor over surgery alone or drugs being given intravenously. The purpose of this study is to better understand if surgical resection of all visible disease with intraperitoneal administration of heated cisplatin can improve outcomes from metastatic ACC. Additionally, the investigators would like to understand associated complications, how quality of life is affected, and if there are specific tumor factors that affect survival and recurrence after this procedure. To be eligible for the study, participants must have ACC that can be seen on CT imaging. A surgeon must believe the disease can be safely removed, and that the patient can tolerate the operation and potential complications. Patients who are successfully debulked of visible tumor will undergo heated intra-abdominal chemotherapy with Cisplatin at the same operation. Associate investigators in coordination with the Principal Investigator will evaluate patients over 18 years of age for eligibility. This investigation aims to improve quality and length of life in patients with limited options for the treatment of metastatic ACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who are successfully debulked will undergo heated intraperitoneal chemotherapy with cisplatin.
| Arm | Type | Receives |
|---|---|---|
| Surgery with HIPEC | Experimental | Drug: Cisplatin, Drug: Sodium thiosulfate, Procedure: Cytoreductive surgeryCytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.:
- Greater than or equal to 18 years of age
- Able to understand and sign the Informed Consent Document
Key exclusion criteria (13 listed)
- 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 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 (PFT) indicating an forced expiratory volume at one second (FEV1) less than 50% or a diffusing capacity of lung for carbon monoxide (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: PlatinolRoute of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2 Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC) | Drug | Surgery with HIPEC |
| Sodium thiosulfateAlso: Sodium thiosulfate injectionRoute of administration: Intravenous Loading dose of 7.5 gm/m2 over 20 minutes followed by 2.13 gm/m2/hr for 12 hours Drug 2 given intravenously during hyperthermic intraperitoneal chemotherapy (HIPEC) | Drug | Surgery with HIPEC |
| Cytoreductive surgeryAlso: Cytoreductive debulking surgeryStandard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors. | Procedure or surgery | Surgery with HIPEC |
Primary outcome
Progression Free Survival
Time frame: Up 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.
3 secondary outcomes
Morbidity Rate
Time frame: Up to 5 years
Quality of Life (QOL) Score
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuki Sugahara, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Sodium thiosulfate and Cytoreductive surgery in people with Adrenocortical Carcinoma and Peritoneal Carcinomatosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.