Background:
Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy
that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis.
These are tumors that have spread to the lining of the abdomen from other cancers.
Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy
drugs used in HIPEC.
Objective:
To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using
a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System.
Eligibility:
Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed
safely with surgery.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Computed tomography (CAT) scan
Other imaging scans, as needed
Electrocardiogram (EKG)
Tumor biopsy, if needed
Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera
will be used to see their organs.
Some screening tests will be repeated in the study.
Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be
used in future research.
Participants will have CRS. As many of their visible tumors will be removed as possible.
They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get
chemotherapy through one tube. It will be drained out through the other tube. They will
be in the hospital for 7-21 days after surgery.
Participants will give tumor, blood, and fluid samples for research. They will complete
surveys about their health and quality of life.
Participants will have follow-up visits over 5 years.
Additional locations may be listed on ClinicalTrials.gov for NCT04847063.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
Peritoneal carcinomatosis is uniformly fatal if untreated; improved outcomes are seen
with aggressive cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy
(HIPEC).
The selection of chemotherapeutic agent for HIPEC is largely based on primary tumor
histology and provider preference as opposed to knowledge of the potential efficacy of a
specific agent for an individual patient.
HIPEC is intended to target small or microscopic residual disease following complete
cytoreduction; however, the actual efficacy and additional benefit of HIPEC is in
question.
The SMART System provides an ideal platform upon which to perfuse small peritoneal tumor
tissue implants and simulate HIPEC treatment ex vivo.
Tissue response to simulated ex vivo HIPEC treatment in the SMART System could inform
chemotherapeutic agent selection for subsequent cytoreduction and intra-operative in vivo
HIPEC treatments.
Objective:
To determine the correlation between ex vivo simulated HIPEC in the SMART System and in
vivo HIPEC with respect to two measures of response to treatment: percent necrosis and
Ki-67
Eligibility:
Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian,
or peritoneal mesothelioma histologies
Absence of extra-abdominal metastatic disease
Participant deemed able to undergo complete cytoreduction
Age >= 18 years of age
Design:
This is a Phase I study of cytoreductive surgery (CRS) and heated intraperitoneal
chemotherapy (HIPEC), with randomization to one of two accepted HIPEC treatment regimens
as determined by primary histology.
At the time of cytoreduction, representative peritoneal tumor biopsies will be obtained
before and after intra-operative in vivo HIPEC treatment.
Tumor nodules harvested before intra-operative HIPEC will be placed in the SMART System,
exposed to simulated ex vivo HIPEC treatment, and then perfused, with subsequent
assessment of percent necrosis and Ki-67.
Tumor nodules harvested immediately after intra-operative HIPEC will be placed in the
SMART System and perfused, with subsequent assessment of percent necrosis and Ki-67.
The correlation of percent necrosis and Ki-67 assessment following simulated ex vivo
HIPEC and intra-operative in vivo HIPEC will be determined.
Lead OrganizationNational Cancer Institute
Principal InvestigatorAndrew M Blakely