Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)

Korábbi kezelés

• Pre-cytoreductive surgery:
• Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery
• Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
• Patient deemed not medically suitable to receive mEPIC protocol according to surgical team
• Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.

Más betegség

• Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement
• Known allergic reaction or major toxicity to Fluorouracil
• Contraindications to Fluorouracil, including history of coronary spasm and/or known dihydropyrimidine dehydrogenase deficiency
• Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy.
  • Post-cytoreductive surgery:
• Active infection
• Any condition that would preclude the ability to deliver appropriate IP therapy.

Egyéb

• Pregnancy
• Uncorrected coagulopathy and/or thrombocytopenia and/or neutropenia
• Hemodynamic and / or respiratory compromise

• Patient's age 18 years or older, both genders.
• In good general health as evidenced by an ECOG score of 0 or 1.
• Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (< 12 months after primary diagnosis) or metachronous (>12 months after the primary diagnosis)
• Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate. (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +/- biopsy
• Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC
• Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the study duration
• Hematology: Absolute neutrophil count (ANC) ≥ 1,500/ μL; Platelets > 75,000/ μL.
• Adequate Renal function Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min.
• Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL).