Second Look Laparoscopy in Colorectal Cancer

Phase 2

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Laparoscopy; Procedure: peritonectomy; Drug: Folinic Acid; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: systemic chemotherapy

• Registration Number: NCT01628211
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Histologic diagnosis colorectal adenocarcinoma
• Mucinous histotype
• Stage I-III
• Radical (R0) surgical resection of primary tumor
• CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery
• Age ≥ 18 ≤ 65 years
• Performance Status ECOG ≤1
• Normal hepatic, renal and hematologic function
• Adjuvant chemotherapy permitted
• Signed informed consent

Exclusion Criteria

• Residual disease after surgical resection of primary tumor
• Distant metastasis
• Active systemic infection
• Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum
• Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer)
• Pregnancy or lactation
• Refusal or incapability of providing informed consent
• Impossibility of complying with study schedules and follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second look laparoscopy	Laparoscopy	Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Second look laparoscopy	peritonectomy	Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Second look laparoscopy	Folinic Acid	Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Second look laparoscopy	systemic chemotherapy	Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Second look laparoscopy	5-Fluorouracil	Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Second look laparoscopy	Oxaliplatin	Second look laparoscopy to evaluate for and treat peritoneal carcinosis

Primary Outcome Measures

Name	Time	Method
overall survival	two years

Secondary Outcome Measures

Name	Time	Method
changes in quality of life	6 months	quality of life is measured at baseline and 6 months after randomization
worst grade adverse event per patient	7 months	toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm	6 months
list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery	two years	description of therapies and outcomes for those patients who were not randomized due to presence of disease
number of patients with radiologic evidence of disease after initial surgery	6 months
overall survival	five years

Trial Locations

Locations (1)

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico; 🇮🇹 Napoli, Italy