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Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma (HIPECT4)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614534
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Study Description
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Brief Summary:
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: MITOMYCIN-C 40 mg Procedure: Proactive cytoreductive surgery Phase 3

Detailed Description:

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.

This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
Actual Study Start Date : November 16, 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Proactive cytoreductive surgery + HIPEC
Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes).
 Drug: MITOMYCIN-C 40 mg
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.
Active Comparator: Proactive cytoreductive surgery
Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).
 Procedure: Proactive cytoreductive surgery
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)


Outcome Measures
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Primary Outcome Measures :
  1. Locoregional Control (LC) [ Time Frame: 3 years ]
    Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months and 36 months after surgery ]
    Evaluate the effect of the addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years overall survival rate (%OS).

  2. Disease Free Survival [ Time Frame: 12 months and 36 months after surgery ]
    Evaluate the effect of addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years disease free survival rate (% DFS).

  3. Evaluation of the morbidity and mortality related with the treatment [ Time Frame: 36 months after surgery ]
    Evaluate the safety (treatment-related morbidity and mortality) of addition of HIPEC with Mitomycin C to cytoreductive surgery in locally advanced colo-rectal cancer. It will be measured by the incidence rate of adverse events and deaths.

  4. HIPEC technique operating time [ Time Frame: 36 months after surgery ]
    Average operating time calculation.

  5. HIPEC technique length of hospital stay [ Time Frame: 36 months after surgery ]
    Average length of hospital stay calculation.

  6. HIPEC technique re-admission rate [ Time Frame: 36 months after surgery ]
    Average re-admission rate calculation.

  7. HIPEC technique laparoscopic vs laparotomy approach [ Time Frame: 36 months after surgery ]
    With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.

  8. HIPEC technique open vs. closed HIPEC technique [ Time Frame: 36 months after surgery ]
    With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.

  9. Quality of life questionnaire QLQ-C30 [ Time Frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery ]
    With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-C30.

  10. Quality of life questionnaires QLQ-CR29 [ Time Frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery ]
    With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-CR29.


Eligibility Criteria
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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. Male and female patients between the ages of 18 and 75 years;
  2. Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
  3. Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
  4. Metastatic extent: M0;
  5. Karnofsky index >70 or Performance status ≤2;
  6. Informed consent properly completed.

Exclusion Criteria:

  1. Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage.
  2. Presence of unresectability criteria;
  3. Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery.
  4. Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
  5. Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor).
  6. Severely altered liver, kidney and cardiovascular function;
  7. Intolerance to treatment;
  8. Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
  9. Pregnant or breastfeeding women.
Contacts and Locations
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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): NCT02614534


Locations
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Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Investigators
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Principal Investigator: Álvaro Arjona Sánchez, MD Hospital Universitario Reina Sofía
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT02614534    
Other Study ID Numbers: FCO-HIP-2015-01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The individual participant data will be available.

Individual parcicipant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices)

The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form.

The data will be available beginning 9 months and ending 36 months following article publication.

With whom? Researchers who provide a methodologically sound proposal.

For what types of analyses? for individual participant data meta-analysis.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will be available beginning 9 months and ending 36 months following article publication.
Access Criteria: To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.
Keywords provided by Maimónides Biomedical Research Institute of Córdoba:
HIPEC
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
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