Second Look Laparoscopy in Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Laparoscopy
* Procedure: peritonectomy
* Drug: Folinic Acid
* Drug: 5-Fluorouracil
* Drug: Oxaliplatin
* Drug: systemic chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second look laparoscopy<br>Second look laparoscopy to evaluate for and treat peritoneal carcinosis | Procedure: Laparoscopy<br>* second look laparoscopy to evaluate for peritoneal carcinosis<br>Procedure: peritonectomy<br>* for patients with PCI < 20<br>Drug: Folinic Acid<br>* 20 mg/m2 IV given just before HIPEC for patients with PCI < 20<br>Drug: 5-Fluorouracil<br>* 400 mg/m2 IV given just before HIPEC in patients with PCI < 20<br>Drug: Oxaliplatin<br>* 460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20<br>Drug: systemic chemotherapy<br>* according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20<br>|
| No Intervention: standard follow up<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| overall survival |  | five years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer