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

NCT ID: NCT04929015

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2024-11-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (biospecimen collection)

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.

Group Type: EXPERIMENTAL

Biospecimen Collection - blood and tissue sample collection

Intervention Type: PROCEDURE

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

Electronic Health Record Review

Intervention Type: OTHER

Medical record reviewed

Interventions

Biospecimen Collection - blood and tissue sample collection

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: PROCEDURE

Electronic Health Record Review

Medical record reviewed

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Henry Richard Alexander, MD

Chief Surgical Officer, Rutgers Cancer Institute of New Jersey

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry R Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

RWJBarnabas Health - Cooperman Barnabas, Livingston

Livingston, New Jersey, United States

Site Status: RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Henry Richard Alexander, MD

Role: primary

ha364@cinj.rutgers.edu

732-235-3391

Henry R Alexander, MD

Role: primary

ha364@cinj.rutgers.edu

732-235-3391

Other Identifiers

072013

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-02123

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro2021000017

Identifier Type: -

Identifier Source: org_study_id