Trial · NCT01833832
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
NCT01833832, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Surgery and Heated Chemotherapy for Adrenocortical Carcinoma. Trials, record NCT01833832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01833832
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
- NCT number
- NCT01833832
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adrenocortical Carcinoma, Peritoneal Carcinomatosis
- Interventions
- Cisplatin, Cytoreductive surgery, sodium thiosulfate
- First posted
- 2013-04-17
- Last updated
- 2019-07-30
- Results first posted
- 2019-07-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraperitoneal Progression Free Survival (PFS) | Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months | 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. |
| Secondary | Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure | Patients were assessed every 3 months up to an average of 17 months. | 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. |
| Secondary | Percentage of Participants Who Survived 5-years Post Treatment | 5 years | Percentage of participants who are alive after treatment. |
| Secondary | 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, 6 weeks post surgery, and 3 months post 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. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraperitoneal Progression Free Survival (PFS) | Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months | One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy. | Months | MEDIAN |
| SECONDARY | Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure | Patients were assessed every 3 months up to an average of 17 months. | One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Survived 5-years Post Treatment | 5 years | 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 | NUMBER |
| SECONDARY | 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, 6 weeks post surgery, and 3 months post surgery | One patient could not be optimally cytoreduced for hyperthermic intraperitoneal chemotherapy (HIPEC) and therefore did not receive intraperitoneal chemotherapy. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 34 months and 28 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraperitoneal Progression Free Survival (PFS) | Cytoreductive Surgery Followed by HIPEC | 19 | Full Range 3 to 66 | Months | |
| Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure | Cytoreductive Surgery Followed by HIPEC | 0 | Participants | ||
| Percentage of Participants Who Survived 5-years Post Treatment | Cytoreductive Surgery Followed by HIPEC | 66.7 | 95% Confidence Interval 28.2 to 87.8 | percentage of participants | |
| 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 | Cytoreductive Surgery Followed by HIPEC | Prior to surgery | 82.6 | Full Range NA to NA | scores on a scale |
| 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 | Cytoreductive Surgery Followed by HIPEC | 6 weeks after surgery | 76.4 | Full Range NA to NA | scores on a scale |
| 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 | Cytoreductive Surgery Followed by HIPEC | 3 months after surgery | 80.2 | Full Range NA to NA | scores on a scale |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Cytoreductive Surgery Followed by HIPEC | 8 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cytoreductive Surgery Followed by HIPEC | 11 | |
| Overall Study | COMPLETED | Cytoreductive Surgery Followed by HIPEC | 10 | |
| Overall Study | NOT COMPLETED | Cytoreductive Surgery Followed by HIPEC | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cytoreductive Surgery Followed by HIPEC | 2 | 11 | 2 |
| other | Blood bilirubin increased | Investigations | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| other | Hoarseness | Respiratory, thoracic and mediastinal disorders | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| other | Hypokalemia | Metabolism and nutrition disorders | Cytoreductive Surgery Followed by HIPEC | 3 | 11 | 5 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Cytoreductive Surgery Followed by HIPEC | 5 | 11 | 7 |
| other | Platelet count decreased | Investigations | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| other | Urinary tract infection | Infections and infestations | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| other | Wound infection | Infections and infestations | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | Cytoreductive Surgery Followed by HIPEC | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cytoreductive Surgery Followed by HIPEC | 3 | 11 |
| Total, other adverse events | Cytoreductive Surgery Followed by HIPEC | 8 | 11 |
| Total, serious adverse events | Cytoreductive Surgery Followed by HIPEC | 1 | 11 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01833832
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