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Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)

Primary Purpose

Appendix Carcinoma by AJCC V8 Stage, Colorectal Carcinoma by AJCC V8 Stage, Digestive System Neoplasm

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Biospecimen Collection - blood and tissue sample collection

Electronic Health Record Review

About this trial

This is an interventional diagnostic trial for Appendix Carcinoma by AJCC V8 Stage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

RWJBarnabas Health - Cooperman Barnabas, LivingstonRecruiting
Rutgers Cancer Institute of New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (biospecimen collection)

Arm Description

Patients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation. Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years. Patients undergo tissue collection before or during surgery and their medical records are reviewed.

Outcomes

Primary Outcome Measures

Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)

Will compare results with clinical staging of CRS (surgical staging, surgical outcomes, Peritoneal Carcinoma Index [PCI] and cytoreduction [CC] score). ctDNA clearance rate defined as the % of patients on our protocol with undetectable ctDNA. Will associate ctDNA changes with clinical response by Response Evaluation Criteria in Solid Tumors and surgical staging, surgical outcomes, PCI and CC score using standard T-testing, log-rank analysis or similar non-parametric testing.

Correlation of ctDNA clearance with activity of chemotherapy

Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op

Secondary Outcome Measures

Positivity rate of ctDNA in patients with peritoneal carcinomatosis

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.

ctDNA will be obtained at baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years. ctDNA from blood samples will be compared with the results of NSG analysis from original tumor tissue

Associations between CEA levels and ctDNA levels

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Associations between CA19.9 levels and ctDNA levels

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Associations between CA125 levels and ctDNA levels

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Full Information

NCT ID

NCT04929015

First Posted

May 31, 2021

Last Updated

July 20, 2023

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04929015

Brief Title

Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)

Official Title

Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 29, 2021 (Actual)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with. The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.

Detailed Description

This study is an exploratory analysis of the utility of ctDNA as a sensitive biomarker in patients with Peritoneal Carcinomatosis treated with chemotherapy, CRS and/or hyperthermic intraperitoneal chemotherapy (HIPEC). OBJECTIVES: I. To measure changes in circulating tumor deoxyribonucleic acid (ctDNA) in patients with peritoneal carcinomatosis (PC) from gastrointestinal (GI) cancers who are candidates for cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC). II. To determine the percentage of patients on protocol with undetectable ctDNA (clearance rate) after complete CRS. III. To identify any associations between clinical staging of CRS and measurable ctDNA. IV. To assess changes in ctDNA levels in response to chemotherapy in patients with PC. V. To guide treatment based on ctDNA response. OUTLINE: Patients may receive induction chemotherapy at the discretion of the treating physician for up to 6 months. Patients undergo blood sample collection for ctDNA analysis at baseline, post chemotherapy/pre-surgery, 3-4 weeks post CRS/HIPEC, then every 3 months over 2 years. Patients also undergo tissue collection before or during surgery and their medical records are reviewed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendix Carcinoma by AJCC V8 Stage, Colorectal Carcinoma by AJCC V8 Stage, Digestive System Neoplasm, Esophageal Carcinoma by AJCC V8 Stage, Gastric Carcinoma by AJCC V8 Stage, Liver and Intrahepatic Bile Duct Carcinoma, Peritoneal Carcinomatosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (biospecimen collection)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection - blood and tissue sample collection

Intervention Description

The original tissue sample from each patient will be obtained at time of surgery or prior to surgery. Plasma for ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up 2 years

Intervention Type

Other

Intervention Name(s)

Electronic Health Record Review

Intervention Description

Medical record reviewed

Primary Outcome Measure Information:

Title

Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)

Description

Time Frame

Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Title

Correlation of ctDNA clearance with activity of chemotherapy

Description

Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op

Time Frame

Baseline, pre-surgery, 3-4 weekd post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Secondary Outcome Measure Information:

Title

Positivity rate of ctDNA in patients with peritoneal carcinomatosis

Description

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Time Frame

Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Title

ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.

Description

Time Frame

Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Title

Associations between CEA levels and ctDNA levels

Description

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Time Frame

Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)

Title

Associations between CA19.9 levels and ctDNA levels

Description

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Time Frame

Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)

Title

Associations between CA125 levels and ctDNA levels

Description

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

Time Frame

Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry R Alexander, MD

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

RWJBarnabas Health - Cooperman Barnabas, Livingston

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henry Richard Alexander, MD

Phone

732-235-3391

ha364@cinj.rutgers.edu

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henry R Alexander, MD

Phone

732-235-3391

ha364@cinj.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)

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