Heated chemo during surgery shows promise for rare abdominal cancer
NCT ID NCT03127774
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving heated chemotherapy directly into the abdomen during surgery can help people with a rare and aggressive adrenal cancer that has spread within the belly. About 30 participants will have surgery to remove visible tumors, followed by a wash of heated cisplatin. The main goal is to see how long they live without the cancer coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin (heated chemotherapy given into the abdomen during surgery)
- What this could lead to
- If successful, this approach could offer a way to delay cancer recurrence in patients with adrenocortical carcinoma that has spread within the abdomen.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to all patients. Heated chemotherapy also carries risks of serious side effects like kidney damage and infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2017
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 99 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA * 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 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 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University Medical Center
New York, New York, 10032-3729, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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