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Second Look Laparoscopy in Colorectal Cancer

NCT01628211 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • C. Sassaroli, M.D. · National Cancer Institute, Naples

  • A Cassata, M.D. · University of Campania Luigi Vanvitelli

  • M.C. Piccirillo, M.D. · NCI Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01628211 on ClinicalTrials.gov