Second Look Laparoscopy in Colorectal Cancer (HIPEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01628211
Recruitment Status : Recruiting
First Posted : June 26, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
National Cancer Institute, Naples

June 20, 2012
June 26, 2012
March 29, 2017
April 2012
September 2017   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: two years ]
Same as current
Complete list of historical versions of study NCT01628211 on Archive Site
  • number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm [ Time Frame: 6 months ]
  • changes in quality of life [ Time Frame: 6 months ]
    quality of life is measured at baseline and 6 months after randomization
  • overall survival [ Time Frame: five years ]
  • worst grade adverse event per patient [ Time Frame: 7 months ]
    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 ]
  • list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery [ Time Frame: two years ]
    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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
    • 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 Identifier (NCT Number) in Medline.
Same as current
June 2018
September 2017   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571
Contact: Marilina Piccirillo, M.D. +39 081 5903383
Not Provided
Not Provided
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. University of Campania "Luigi Vanvitelli"
Principal Investigator: M.C. Piccirillo, M.D. NCI Naples
National Cancer Institute, Naples
March 2017

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