NCT01628211

Second Look Laparoscopy in Colorectal Cancer

Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopy	second look laparoscopy to evaluate for peritoneal carcinosis
PROCEDURE	peritonectomy	for patients with PCI \< 20
DRUG	Folinic Acid	20 mg/m2 IV given just before HIPEC for patients with PCI \< 20
DRUG	5-Fluorouracil	400 mg/m2 IV given just before HIPEC in patients with PCI \< 20
DRUG	Oxaliplatin	460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20
DRUG	systemic chemotherapy	according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20

Timeline

• Start date: 2012-04-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2012-06-26
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy