PERitoneal Carcinomatosis LEveraging ctDNA guided treatment Study in GI Cancer (PERICLES Study).
1. To measure changes in ctDNA in patients with PC from GI cancers who are candidates for Cytoreductive Surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC).
2. To determine the clearance rate of ctDNA after complete CRS.
3. To identify any associations between clinical staging of CRS and measurable ctDNA.
4. To assess changes in ctDNA levels in response to chemotherapy in patients with PC.
5. To guide treatment based on ctDNA response.
Ill-Defined Sites
Colon
Esophagus
Stomach
Rectum
Pancreas
Other Digestive Organ
Small Intestine
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion Criteria
- Patients with histologically confirmed carcinoma of presumed gastrointestinal origin
(gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal
carcinomatosis of apparent GI primary) with documented diffuse peritoneal
carcinomatosis, either by conventional imaging studies, positive ascitic fluid
analysis, or surgical staging
- Measurable or evaluable disease by cross-sectional imaging studies
- Patients must be candidates for possible surgical cytoreduction (with or without
HIPEC) as determined by a study surgical oncologist
- Age >= 18 years
- Estimated life expectancy of at least 12 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patients must sign informed consent
- Be willing to present for medical exams, blood draws and imaging as scheduled in
protocol
- Be able to donate two 10 mL tubes of blood every 3 months
- Women of childbearing potential will undergo routine screening evaluation for
pregnancy prior to enrollment and be managed per standard of care
Exclusion Criteria
- Patients without a confirmed pathologic diagnosis of carcinoma
- Second uncontrolled primary malignancy
- Patients who are pregnant
- Patients who cannot undergo a therapeutic surgical cytoreduction
- Bone marrow transplant or other organ transplant recipient
- Any unstable, serious co-existing medical conditions including but not limited to
myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
clinically evident congestive heart failure, or cerebrovascular accident within 6
months prior to screening
- Patients with cardiovascular or pulmonary risk factors contributing to high risk for
surgical complications, at the discretion of the surgeon
- Serious concomitant systemic disorder that would compromise the safety of the patient
or compromise the patient's ability to complete the study, at the discretion of the
investigator
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.