RecruitingPhase 2NCT03127774

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma


Sponsor

Columbia University

Enrollment

30 participants

Start Date

Sep 22, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Objectives: \- To determine intraperitoneal (IP) progression free survival after optimal debulking and heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of adrenocortical cancer. \- Determine morbidity of this procedure in this patient population. \- Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess. \- Examine patterns of recurrence (local versus systemic). \- Determine overall survival after optimal debulking and HIPEC in patients with IP spread of adrenocortical cancer.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of surgery and heated chemotherapy delivered directly into the abdomen (called HIPEC) as a treatment for adrenocortical carcinoma (a rare cancer of the adrenal gland) that has spread inside the belly. **You may be eligible if...** - You have been diagnosed with adrenocortical carcinoma (confirmed by biopsy) - Most of your cancer is confined to the abdominal cavity - Your tumors are considered removable based on CT or PET scan imaging - Any spread to the liver involves 5 or fewer lesions and can be fully removed - Any lung spread involves 3 or fewer lesions and can be fully removed **You may NOT be eligible if...** - Your cancer has spread widely beyond the abdomen in a way that cannot be fully removed - You have large amounts of fluid in the belly (ascites) or bowel blockage - Your overall health is too poor for major surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2 Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)

DRUGSodium thiosulfate

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)

PROCEDURECytoreductive surgery

Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.


Locations(1)

Columbia University Medical Center

New York, New York, United States

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NCT03127774


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