Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Phase 2

Recruiting

• Conditions: Peritoneal Carcinomatosis; Adrenocortical Carcinoma
• Interventions: Drug: Cisplatin; Drug: Sodium thiosulfate; Procedure: Cytoreductive surgery

• Registration Number: NCT03127774
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

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 an surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.

Study Timeline

• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Study Start: 2017-09-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery with HIPEC	Cisplatin	Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Surgery with HIPEC	Sodium thiosulfate	Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Surgery with HIPEC	Cytoreductive surgery	Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Up to 5 years	The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.

Secondary Outcome Measures

Name	Time	Method
Morbidity Rate	Up to 5 years	The frequency of post-operative complications.
Quality of Life (QOL) Score	Up to 5 years	This measures the impact of surgery and HIPEC on quality of life.
Overall Survival	Up to 5 years	The length of time people are alive after surgery and HIPEC for adrenocortical cancer.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States