Second Look Laparoscopy in Colorectal Cancer

Colorectal Cancer Clinical Trial

— HIPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01628211
• Other study ID #: HIPEC
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Francesco Perrone, M.D., Ph.D.
• Phone: +39 081 5903571
• Email: francesco.perrone[@]usc-intnapoli.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Laparoscopy
second look laparoscopy to evaluate for peritoneal carcinosis
• peritonectomy
for patients with PCI < 20

Drug:
• Folinic Acid
20 mg/m2 IV given just before HIPEC for patients with PCI < 20
• 5-Fluorouracil
400 mg/m2 IV given just before HIPEC in patients with PCI < 20
• Oxaliplatin
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20
• systemic chemotherapy
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

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