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Second Look Laparoscopy in Colorectal Cancer (HIPEC)

This study is currently recruiting participants.
Verified January 2013 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: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 2016
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628211

Contacts
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

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

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01628211     History of Changes
Other Study ID Numbers: HIPEC
Study First Received: June 20, 2012
Last Updated: January 15, 2013
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:
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 17, 2013