Trial Outcomes & Findings for Surgery and Heated Chemotherapy for Adrenocortical Carcinoma (NCT NCT01833832)
NCT ID: NCT01833832
Last Updated: 2019-07-30
Results Overview
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.
COMPLETED
PHASE2
11 participants
Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months
2019-07-30
Participant Flow
Participant milestones
| Measure |
Cytoreductive Surgery Followed by HIPEC
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
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cytoreductive Surgery Followed by HIPEC
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
|
|---|---|
|
Overall Study
Pt could not be cytoreduced for HIPEC
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1
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Baseline Characteristics
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
Baseline characteristics by cohort
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=11 Participants
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
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
41.48 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
|
Tumor Stage (AJCC) at Diagnosis
Stage I
|
20 percentage of participants
n=99 Participants
|
|
Tumor Stage (AJCC) at Diagnosis
Stage II
|
50 percentage of participants
n=99 Participants
|
|
Tumor Stage (AJCC) at Diagnosis
Stage III
|
10 percentage of participants
n=99 Participants
|
|
Tumor Stage (AJCC) at Diagnosis
Stage IV
|
0 percentage of participants
n=99 Participants
|
|
Tumor Stage (AJCC) at Diagnosis
Unknown
|
20 percentage of participants
n=99 Participants
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PRIMARY outcome
Timeframe: Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 monthsPopulation: One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.
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.
Outcome measures
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=10 Participants
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
|
|---|---|
|
Intraperitoneal Progression Free Survival (PFS)
|
19 Months
Interval 3.0 to 66.0
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SECONDARY outcome
Timeframe: Patients were assessed every 3 months up to an average of 17 months.Population: One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.
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.
Outcome measures
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=10 Participants
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
|
|---|---|
|
Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure
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0 Participants
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SECONDARY outcome
Timeframe: 5 yearsPopulation: Nine patients underwent cytoreduction and HIPEC, including one patient who recurred and was re-treated (n = 10 treatments). One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.
Percentage of participants who are alive after treatment.
Outcome measures
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=9 Participants
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
|
|---|---|
|
Percentage of Participants Who Survived 5-years Post Treatment
|
66.7 percentage of participants
Interval 28.2 to 87.8
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SECONDARY outcome
Timeframe: Prior to surgery, 6 weeks post surgery, and 3 months post surgeryPopulation: One patient could not be optimally cytoreduced for hyperthermic intraperitoneal chemotherapy (HIPEC) and therefore did not receive intraperitoneal chemotherapy.
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.
Outcome measures
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=11 Participants
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
|
|---|---|
|
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
Prior to surgery
|
82.6 scores on a scale
The full range data is unavailable because the primary source documents are not available. All of the personnel involved in the running of the study, data acquisition, and the person who put together the manuscript have all left the NIH.
|
|
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
6 weeks after surgery
|
76.4 scores on a scale
The full range data is unavailable because the primary source documents are not available. All of the personnel involved in the running of the study, data acquisition, and the person who put together the manuscript have all left the NIH.
|
|
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
3 months after surgery
|
80.2 scores on a scale
The full range data is unavailable because the primary source documents are not available. All of the personnel involved in the running of the study, data acquisition, and the person who put together the manuscript have all left the NIH.
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 34 months and 28 days.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.
Outcome measures
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=11 Participants
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
|
|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
8 Participants
|
Adverse Events
Cytoreductive Surgery Followed by HIPEC
Serious adverse events
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=11 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
Other adverse events
| Measure |
Cytoreductive Surgery Followed by HIPEC
n=11 participants at risk
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
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
3/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.5%
5/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
|
Infections and infestations
Wound infection
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place