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RECRUITING
NCT03127774
PHASE2

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2017-09-22

Completion Date

2025-12

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

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

DRUG

Sodium 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)

PROCEDURE

Cytoreductive 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