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Second Look Laparoscopy in Colorectal Cancer (HIPEC)

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopy
peritonectomy
Folinic Acid
5-Fluorouracil
Oxaliplatin
systemic chemotherapy
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Second look laparoscopy

standard follow up

Arm Description

Second look laparoscopy to evaluate for and treat peritoneal carcinosis

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2012
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT01628211
Brief Title
Second Look Laparoscopy in Colorectal Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Second look laparoscopy
Arm Type
Experimental
Arm Description
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Arm Title
standard follow up
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Intervention Description
second look laparoscopy to evaluate for peritoneal carcinosis
Intervention Type
Procedure
Intervention Name(s)
peritonectomy
Intervention Description
for patients with PCI < 20
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Intervention Description
20 mg/m2 IV given just before HIPEC for patients with PCI < 20
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
400 mg/m2 IV given just before HIPEC in patients with PCI < 20
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Description
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20
Primary Outcome Measure Information:
Title
overall survival
Time Frame
two years
Secondary Outcome Measure Information:
Title
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm
Time Frame
6 months
Title
changes in quality of life
Description
quality of life is measured at baseline and 6 months after randomization
Time Frame
6 months
Title
overall survival
Time Frame
five years
Title
worst grade adverse event per patient
Description
toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment
Time Frame
7 months
Title
number of patients with radiologic evidence of disease after initial surgery
Time Frame
6 months
Title
list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery
Description
description of therapies and outcomes for those patients who were not randomized due to presence of disease
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Perrone, M.D., Ph.D.
Phone
+39 081 5903571
Email
francesco.perrone@usc-intnapoli.net
First Name & Middle Initial & Last Name or Official Title & Degree
Marilina Piccirillo, M.D.
Phone
+39 081 5903383
Email
marilina.piccirillo@usc-intnapoli.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Sassaroli, M.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A Cassata, M.D.
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M.C. Piccirillo, M.D.
Organizational Affiliation
NCI Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Second Look Laparoscopy in Colorectal Cancer

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