Second Look Laparoscopy in Colorectal Cancer (HIPEC)

This study is currently recruiting participants.
Verified February 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01628211
First received: June 20, 2012
Last updated: February 20, 2014
Last verified: February 2014

June 20, 2012
February 20, 2014
April 2012
December 2015   (final data collection date for primary outcome measure)
overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01628211 on ClinicalTrials.gov Archive Site
  • number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • changes in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    quality of life is measured at baseline and 6 months after randomization
  • overall survival [ Time Frame: five years ] [ Designated as safety issue: No ]
  • worst grade adverse event per patient [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery [ Time Frame: two years ] [ Designated as safety issue: No ]
    description of therapies and outcomes for those patients who were not randomized due to presence of disease
Same as current
Not Provided
Not Provided
 
Second Look Laparoscopy in Colorectal Cancer
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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
  • Experimental: Second look laparoscopy
    Second look laparoscopy to evaluate for and treat peritoneal carcinosis
    Interventions:
    • Procedure: Laparoscopy
    • Procedure: peritonectomy
    • Drug: Folinic Acid
    • Drug: 5-Fluorouracil
    • Drug: Oxaliplatin
    • Drug: systemic chemotherapy
  • No Intervention: standard follow up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Marilina Piccirillo, M.D. +39 081 5903383 marilina.piccirillo@usc-intnapoli.net
Italy
 
NCT01628211
HIPEC
No
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: C. Sassaroli, M.D. National Cancer Institute, Naples
Principal Investigator: A Cassata, M.D. Second University of Naples
Principal Investigator: M.C. Piccirillo, M.D. NCI Naples
National Cancer Institute, Naples
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP