A Phase 2 interventional study of Cisplatin and Cytoreductive surgery in Adrenocortical Carcinoma and Peritoneal Carcinomatosis, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
Eligibility:
Design:
Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.
Patients will be evaluated by associate investigators in coordination with the Principal Investigator for eligibility. Due to its exploratory nature, up to 30 patients may be enrolled to obtain 24 evaluable patients. (Patients must undergo successful debulking and HIPEC to be considered evaluable.)
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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All disease should be deemed resectable based on imaging studies e.g.:
Hematology:
Chemistry:
EXCLUSION CRITERIA
Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., greater than 65yo, diabetes, history of hypertension, elevated low-density lipoproteins (LDL), first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction less than 40%.
Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is less than 50% of expected.
Note: Any diagnosis of portal hypertension or clinical stigmata of such including but not limited to gastric or esophageal varices, umbilical vein varices or telangiectasias.
Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin
Drug: Cisplatin · Procedure: Cytoreductive surgery · Drug: sodium thiosulfate
Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.
Also known as: Platinol
Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.
sodium thiosulfate will be given to limit the toxicity of cisplatin
Intraperitoneal Progression Free Survival (PFS)
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.
Time frame: Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months
Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure
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.
Time frame: Patients were assessed every 3 months up to an average of 17 months.
Percentage of Participants Who Survived 5-years Post Treatment
Percentage of participants who are alive after treatment.
Time frame: 5 years
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
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.
Time frame: Prior to surgery, 6 weeks post surgery, and 3 months post surgery
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
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.
Time frame: Date treatment consent signed to date off study, approximately 34 months and 28 days.
| Milestone | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
| Withdrew: Pt could not be cytoreduced for hipec | 1 |
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.
| Months | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Intraperitoneal Progression Free Survival (PFS) | 19 (3 to 66) |
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.
| Participants | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure | 0 |
Percentage of participants who are alive after treatment.
| percentage of participants | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Percentage of Participants Who Survived 5-years Post Treatment | 66.7 (28.2 to 87.8) |
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.
| scores on a scale | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Prior to surgery | 82.6 (NA to NA) |
| 6 weeks after surgery | 76.4 (NA to NA) |
| 3 months after surgery | 80.2 (NA to NA) |
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.
| Participants | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 8 |
Collected over Date treatment consent signed to date off study, approximately 34 months and 28 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytoreductive Surgery Followed by HIPEC | 3/11 (27.3%) | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Abdominal painGastrointestinal disorders | 1/11 |
| Event | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| HypophosphatemiaMetabolism and nutrition disorders | 5/11 |
| HypokalemiaMetabolism and nutrition disorders | 3/11 |
| AnemiaBlood and lymphatic system disorders | 2/11 |
| Alanine aminotransferase increasedInvestigations | 1/11 |
| Blood bilirubin increasedInvestigations | 1/11 |
| HoarsenessRespiratory, thoracic and mediastinal disorders | 1/11 |
| Platelet count decreasedInvestigations | 1/11 |
| Urinary tract infectionInfections and infestations | 1/11 |
| Wound infectionInfections and infestations | 1/11 |
| Age, Categorical(Participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Age, Continuous(years) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Mean | 41.48 ± 11.3 |
| Sex: Female, Male(Participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Female | 8 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| United States | 11 |
| Tumor Stage (AJCC) at Diagnosis(percentage of participants) | Cytoreductive Surgery Followed by HIPEC |
|---|---|
| Stage I | 20 |
| Stage II | 50 |
| Stage III | 10 |
| Stage IV | 0 |
| Unknown | 20 |
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National Cancer Institute (NCI)