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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

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ClinicalTrials.gov Identifier: NCT02614534
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

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 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.


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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : November 2015
Estimated Primary Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 metastasis (M1);
  2. Presence of unresectability criteria;
  3. Urgent intervention for obstruction or perforation;
  4. Extraperitoneal rectal cancer (avoiding alterations for neoadyuvance);
  5. Coexistence with another malignant neoplastic disease;
  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.

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


Contacts
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Contact: Blanca Quijano Ruiz, Pharmacist (+34) 957 736 484 blanca.quijano@imibic.org

Locations
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Spain
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain, 14004
Contact: Blanca Quijano Ruiz, Pharmacist    (+34) 957 736 484    blanca.quijano@imibic.org   
Principal Investigator: Alvaro Arjona, MD         
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba

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     History of Changes
Other Study ID Numbers: FCO-HIP-2015-01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

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