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).
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.
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.
Source: View full study details on ClinicalTrials.gov
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