Second Look Laparoscopy in Colorectal Cancer (HIPEC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Laparoscopy; Procedure: peritonectomy; Drug: Folinic Acid; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: systemic chemotherapy

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Second look laparoscopy; Second look laparoscopy to evaluate for and treat peritoneal carcinosis	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
No Intervention: standard follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival		five years
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm		6 months
changes in quality of life	quality of life is measured at baseline and 6 months after randomization	6 months
worst grade adverse event per patient	toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment	7 months
number of patients with radiologic evidence of disease after initial surgery		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	two years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: intraperitoneal chemotherapy; peritoneal carcinosis; hyperthermic chemotherapy; second-look laparoscopy; mucinous colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Hematinics; Fluorouracil; Oxaliplatin; Leucovorin; Levoleucovorin; Folic Acid
• Other Study ID Numbers: HIPEC