Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03127774|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : August 6, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma Peritoneal Carcinomatosis||Drug: Cisplatin Drug: Sodium thiosulfate Procedure: Cytoreductive surgery||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients who are successfully debulked will undergo heated intraperitoneal chemotherapy with cisplatin.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma|
|Actual Study Start Date :||September 22, 2017|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2023|
Experimental: Surgery with HIPEC
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2
Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)
Other Name: Platinol
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)
Other Name: Sodium thiosulfate injection
Procedure: Cytoreductive surgery
Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.
Other Name: Cytoreductive debulking surgery
- Progression Free Survival [ Time Frame: 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.
- Morbidity Rate [ Time Frame: Up to 5 years ]The frequency of post-operative complications.
- Quality of Life (QOL) Score [ Time Frame: Up to 5 years ]This measures the impact of surgery and HIPEC on quality of life.
- Overall Survival [ Time Frame: Up to 5 years ]The length of time people are alive after surgery and HIPEC for adrenocortical cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127774
|Contact: Michael Kluger, MDfirstname.lastname@example.org|
|Contact: Vilma L Rosarioemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032-3729|
|Contact: Michael Kluger, MD 212-305-6514 firstname.lastname@example.org|
|Contact: Vilma Rosario 212-305-6033 email@example.com|
|Principal Investigator: Michael Kluger, MD|
|Sub-Investigator: Antonio T Fojo, MD|
|Principal Investigator:||Michael Kluger, MD||Columbia University|