The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI \> 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI \< 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
second look laparoscopy to evaluate for peritoneal carcinosis
for patients with PCI \< 20
20 mg/m2 IV given just before HIPEC for patients with PCI \< 20
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Napoli, Italy
RECRUITINGoverall survival
Time frame: two years
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm
Time frame: 6 months
changes in quality of life
quality of life is measured at baseline and 6 months after randomization
Time frame: 6 months
overall survival
Time frame: five years
worst grade adverse event per patient
toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment
Time frame: 7 months
number of patients with radiologic evidence of disease after initial surgery
Time frame: 6 months
list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery
description of therapies and outcomes for those patients who were not randomized due to presence of disease
Time frame: two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
400 mg/m2 IV given just before HIPEC in patients with PCI \< 20
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20