Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate

Adrenocortical Carcinoma

Peritoneal Carcinomatosis

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

Cisplatin

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)

Sodium thiosulfate

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

Cytoreductive surgery

Columbia University Medical Center

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

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

The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.

The frequency of post-operative complications.

This measures the impact of surgery and HIPEC on quality of life.

The length of time people are alive after surgery and HIPEC for adrenocortical cancer.

Michael Kluger

Assistant Professor of Surgery

Columbia University

Patients who are successfully debulked will undergo heated intraperitoneal chemotherapy with cisplatin.

CAPECITABINE 500 mg twice a day, orally, continuously DOCETAXEL 60 mg/sqm i.v. over 1 hr on day 1 cycles repeated every 3 weeks Duration of treatment: Chemotherapy should be continued until: progressive disease; unacceptable toxicities; patients' refusal; or upon investigator's judgement is in the best interest for the patient.

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

capecitabine

Docetaxel

International group of endovascular oncology (IGEVO) website

AORMN, Presidio Ospedaliero San Salvatore

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer Patients Previously Treated With Fluoropyrimidine and Platinum Agents MiCADO Study

International Group of Endovascular Oncology

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin
Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.
Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.
sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin

Cytoreductive Surgery Followed by HIPEC

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

American Joint Committee on Cancer (AJCC) - Tumor Stage I-IV with Stage I being the least advanced cancer with the best prognosis, and Stage 4 being the most advanced cancer with the worst prognosis.

Tumor Stage (AJCC) at Diagnosis

Amount of time subject survives without intraperitoneal disease progression after treatment. Disease progression is defined as imageable tumor nodules or increasing ascites persistent on computed tomography (CT) scan as interpreted by the official interpretation of the imaging studies.

Intraperitoneal Progression Free Survival (PFS)

Patients who died following the HIPEC procedure. The HIPEC is a surgical procedure in which two large bore catheters are inserted in the abdominal wall over the liver and pelvis. The physician closes the abdominal fascia and the catheters are connected to a perfusion circuit. The temperature of the catheters is carefully monitored while the physician ensures the perfusion is distributed properly by manually moving the abdomen.

Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure

Percentage of participants who are alive after treatment.

Percentage of Participants Who Survived 5-years Post Treatment

QOL characteristics were collected using The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (QOL) questionnaire version 4, a validated survey that interrogates physical, emotional, functional, and social well being in cancer related issues on a 5-point scale. Scores range from 0 to 108 points. Higher scores are consistent with a better outcome.

The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (FACT-G) (QOL) Score Prior to Surgery, 6 Weeks After Surgery, and 3 Months After Surgery

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Overall Study

Dr. Jeremy Davis

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

adrenocortical carcinoma/حمى

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

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