Combined Neoadjuvant Systemic and PIPAC Therapy (NASPIT) for Patients With Colorectal Peritoneal Metastasis Eligible for CRS and HIPEC: A Prospective Phase II Trial

This is an interventional treatment trial for Metastatic Colorectal Cancer Read More

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study and must be willing to return for follow-up
3. 18 years of age or older.
4. Biopsy (histopathology or cytology) diagnosis of colorectal cancer as defined by the WHO or by cross-sectional imaging reviewed by a board-certified radiologist.
5. Good performance status (ECOG < 2), Karnofski >60.
6. Patients with low or acceptable surgical risk (American Society of Anesthesiology (ASA) score of 3 or less.
7. Patient is a candidate for CRS and HIPEC as discussed and recommended by the institutional disease management team (DMT, Tumor Board)
8. Patient receiving systemic chemotherapy for up to a maximum of 6 months from peritoneal diagnosis management with stable or responsive disease are eligible for the trial.
9. Absolute neutrophil count (ANC) exceeds 1200/mm3, white blood cell count exceeds 4000/mm3 and platelet count is greater than 100,000/mm3
10. An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible
11. Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome); alkaline phosphatase < 2.5 times the upper limit of normal; and, AST less than 1.5 times upper limit of normal [alkaline phosphatase and AST cannot both exceed the upper limit of normal
12. Serum renal functional parameters, BUN and creatinine are within normal limits
13. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening or with negative pregnancy test at screening.
14. Life expectancy of at least six months

Exclusion Criteria:

1. Patients with unresectable (not eligible for CRS/HIPEC) tumors as decided by a multidisciplinary disease management team
2. Patients that already received multiple cycles of systemic chemotherapy of more than 6 months and or show progression of disease on systemic therapy.
3. Patients with extraperitoneal disease.
4. Pregnancy or lactation
5. Patients with low performance status (ECOG > 2 or Karnofski < 60%)
6. Any one or more of the following hematological abnormalities
7. Hgb < 8gm/dl unable to be corrected with transfusion
8. Absolute Neutrophil Count < 1200/mm3
9. White blood cell count < 4000/mm3
10. Platelet count < 100,000/mm3
11. INR > 1.5 (except in patients who are therapeutically AST anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for operation will be eligible)
12. History of hepatic cirrhosis or present hepatic dysfunction
13. Alkaline phosphatase ≥ 2.5 times the upper limit of normal
14. ≥ 1.5 times upper limit of normal
15. Serum bilirubin > 1.5 mg/dl (except for patients with Gilbert's syndrome who must have direct bilirubin ≤ 1.0 mg/dl)
16. Alkaline phosphatase and AST both exceed the upper limit of normal