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Second Look Laparoscopy in Colorectal Cancer (HIPEC)

This study is currently recruiting participants.
Verified March 2017 by National Cancer Institute, Naples
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628211
First Posted: June 26, 2012
Last Update Posted: March 29, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute, Naples
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: April 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. University of Campania "Luigi Vanvitelli"
Principal Investigator: M.C. Piccirillo, M.D. NCI Naples
  More Information

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01628211     History of Changes
Other Study ID Numbers: HIPEC
First Submitted: June 20, 2012
First Posted: June 26, 2012
Last Update Posted: March 29, 2017
Last Verified: March 2017

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics