Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma (NCT03127774) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
United States30 participantsStarted 2017-09-22
Plain-language 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. 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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:
* Abs…