Adrenocortical carcinoma · NCT03127774
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
- Status
- ACTIVE_NOT_RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE2
- Sponsor
- Columbia University
- Registry records
- CTGOV NCT03127774 (ACTIVE_NOT_RECRUITING)Registry last updated 2026-05-06
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · condition · confidence 0.95 | Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation | "Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation" | |
| inclusion inclusion · stage extent · confidence 0.85 | Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation | "resectable or amenable to radiofrequency ablation" | |
| inclusion inclusion · lesion burden · confidence 0.70 | Disease evaluable by CT or Positron Emission Tomography (PET) imaging | "Disease evaluable by CT or Positron Emission Tomography (PET) imaging" | |
| inclusion inclusion · stage extent · confidence 0.90 | All disease should be deemed resectable based on imaging studies | "All disease should be deemed resectable based on imaging studies" | |
| inclusion inclusion · lesion burden · confidence 0.85 | Hepatic metastases (unilateral or bilateral less than or equal to 5 lesions, less than or equal to 15 cm total diameter) | "Hepatic metastases (unilateral or bilateral less than or equal to 5 lesions, less than or equal to 15 cm total diameter)" | |
| inclusion inclusion · lesion burden · confidence 0.85 | Lung metastases (less than or equal to 3 unilateral/bilateral, 9 cm total diameter) | "Lung metastases (less than or equal to 3 unilateral/bilateral, 9 cm total diameter)" | |
| inclusion inclusion · lesion burden · confidence 0.30 | Primary peritoneal metastases (small disease load less than or equal to P2 disease) without massive ascites or intestinal obstruction | "Primary peritoneal metastases (small disease load less than or equal to P2 disease) without massive ascites or intestinal obstruction" | |
| inclusion inclusion · age sex · confidence 0.99 | Greater than or equal to 18 years of age | "Greater than or equal to 18 years of age" | |
| inclusion inclusion · consent · confidence 0.30 | Able to understand and sign the Informed Consent Document | "Able to understand and sign the Informed Consent Document" | |
| inclusion inclusion · performance status · confidence 0.99 | Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 | "Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2" | |
| inclusion inclusion · life expectancy · confidence 0.90 | Life expectancy of greater than three months | "Life expectancy of greater than three months" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy | "Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy" | |
| inclusion inclusion · lab value · confidence 0.95 | Absolute neutrophil count greater than 1500/mm^3 without the support of Filgrastim. | "Absolute neutrophil count greater than 1500/mm\^3 without the support of Filgrastim." | |
| inclusion inclusion · lab value · confidence 0.95 | Platelet count greater than 75,000/mm^3. | "Platelet count greater than 75,000/mm\^3." | |
| inclusion inclusion · lab value · confidence 0.95 | Hemoglobin greater than 8.0 g/dl. | "Hemoglobin greater than 8.0 g/dl." | |
| inclusion inclusion · lab value · confidence 0.95 | 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 creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60 mL/min/1.73 m2" | |
| inclusion inclusion · lab value · confidence 0.95 | serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal | "serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.95 | total serum bilirubin of less than 3 times the upper limit of normal | "a total serum bilirubin of less than 3 times the upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.90 | Prothrombin time (PT) within 2 seconds of the upper limit of normal (INR less than or equal to 1.8) | "Prothrombin time (PT) within 2 seconds of the upper limit of normal (INR less than or equal to 1.8)" | |
| inclusion inclusion · washout · confidence 0.30 | 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. | "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." | |
| inclusion inclusion · consent · confidence 0.30 | Able to understand their disease and the exploratory nature of combining surgery and HIPEC for this histology. | "Able to understand their disease and the exploratory nature of combining surgery and HIPEC for this histology." | |
| exclusion exclusion · comorbidity · confidence 0.30 | Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure. | "Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure." | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of congestive heart failure | "History of congestive heart failure" | |
| exclusion exclusion · organ function · confidence 0.95 | left ventricular ejection fraction (LVEF) less than 40% | "left ventricular ejection fraction (LVEF) less than 40%" | |
| exclusion exclusion · organ function · confidence 0.90 | 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. | "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." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Grade 2 or greater neuropathy | "Grade 2 or greater neuropathy" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant. | "Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Brain metastases or a history of brain metastases | "Brain metastases or a history of brain metastases" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Childs B or C cirrhosis | "Childs B or C cirrhosis" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Evidence of severe portal hypertension by history, endoscopy, or radiologic studies | "Evidence of severe portal hypertension by history, endoscopy, or radiologic studies" | |
| exclusion exclusion · other · confidence 0.90 | Weight less than 30 kg | "Weight less than 30 kg" | |
| exclusion exclusion · comorbidity · confidence 0.90 | 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 | "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" |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
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
Routes in: how this trial is reached and paid for
US trials at ordinary hospitals: routine care is billed
In the US a sponsor funds the study drug and study-specific scans, but the routine care around them is billed to insurance. Without US cover that bill falls on you.
Cost is documented as the barrier that stops roughly 45 percent of US patients joining trials, before any question of being a non-resident. Eligibility on paper does not make a US site reachable. One email to the study coordinator asking what a non-resident without US insurance would be billed settles it either way.
Verify with: The study coordinator listed on the registry record
Ask first; potentially very high
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Sites (1)
United States
- Columbia University Medical Center, New York