Second Look Laparoscopy in Colorectal Cancer (HIPEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples Identifier:
First received: June 20, 2012
Last updated: November 27, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Colorectal Cancer
Procedure: Laparoscopy
Procedure: peritonectomy
Drug: Folinic Acid
Drug: 5-Fluorouracil
Drug: Oxaliplatin
Drug: systemic chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 140
Study Start Date: April 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
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
No Intervention: standard follow up

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628211

Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571
Contact: Marilina Piccirillo, M.D. +39 081 5903383

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico Recruiting
Napoli, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
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
  More Information

Responsible Party: National Cancer Institute, Naples Identifier: NCT01628211     History of Changes
Other Study ID Numbers: HIPEC 
Study First Received: June 20, 2012
Last Updated: November 27, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
hyperthermic chemotherapy
intraperitoneal chemotherapy
second-look laparoscopy
peritoneal carcinosis
mucinous colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 24, 2016