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Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study. (CHECK)

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ClinicalTrials.gov Identifier: NCT03914820
Recruitment Status : Not yet recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief Summary:

This is a phase III randomized, multicenter study with two different arm:

  • experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
  • comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: HIPEC CO2 Procedure: Standard surgery Phase 3

Detailed Description:

This is a phase III randomized, multicenter study with two different arm:

  • experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
  • comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

The HIPEC CO2 regimen will be as reported below:

mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.

Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a phase III randomized, multicenter study with two different arm:

  • experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
  • comparator: standard surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. A Collaborative Randomized Controlled Trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. CHECK STUDY
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Procedure: HIPEC CO2
Prophylactic surgery plus HIPEC CO2 performed with mitomycin

Active Comparator: Comparator
Standard surgey without HIPEC CO2
Procedure: Standard surgery
Standard surgery without HIPEC CO2




Primary Outcome Measures :
  1. Local recurrence free survival (LRFS) [ Time Frame: This outcome measure will be assess approximately 3 years after the last patient enrolled ]
    The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.


Secondary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: This outcome measure will be assess approximately 3 years after the last patient enrolled ]

    Disease Free Survival (DFS) DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

    OS is defined as the time from randomization to death for any cause.


  2. Overall Survival (OS) [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    death for any cause

  3. number of post-surgery complication [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    any type of complication

  4. morbidity [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    evaluated during and after surgery, graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications

  5. duration of surgery [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    timing of surgery

  6. number of patients performing the adjuvant chemotherapy. [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    patients performing the adjuvant chemotherapy

  7. length of hospitalization [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    length of hospitalization

  8. mortality at 30 and 90 days from surgery [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    mortality at 30 and 90 days from surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically documented colorectal adenocarcinoma eligible for R0,

    1. Presurgical or intraoperative stage T4a or T4b primary tumour (TNM 8 th)
    2. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
    3. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
    4. Ovarian metastases (Krukenberg tumor)
  2. Age ≥ 18 and ≤75 years
  3. Written informed consent

Exclusion Criteria:

  1. Distant metastatic disease (even if limited and completely resected)
  2. History of tumour diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
  3. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
  4. Poor general conditions (ECOG > 2).
  5. Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrolment), myocardial infarction (<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II or serious uncontrolled cardiac Arythmia requiring medication
  6. Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min)
  7. Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin> 1.5 upper limit of normal)
  8. Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm3, platelets <100000 / mm3)
  9. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 <50% or DLCO <40% of normal age value).
  10. Pregnancy
  11. History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
  12. Chronic inflammatory bowel disease
  13. Patients with acute bowel obstruction
  14. Refusal to join the study

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): NCT03914820


Contacts
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Contact: Fabio Pacelli, MD 0039063015 ext 7255 fabio.pacelli@policlinicogemelli.it
Contact: Erica Rulli 0039023901 ext 4684 erica.rulli@marionegri.it

Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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Principal Investigator: Fabio Pacelli, MD fabio.pacelli@policlinicogemelli.it

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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03914820     History of Changes
Other Study ID Numbers: IRFMN-CRC- 7813
2019-001437-14 ( EudraCT Number )
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mario Negri Institute for Pharmacological Research:
colorectal cancer, HIPEC CO2, prophylactic surgery , mitomycin

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors