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)
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| ClinicalTrials.gov Identifier: NCT02614534 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2015
Last Update Posted : January 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: MITOMYCIN-C 40 mg Procedure: Proactive cytoreductive surgery | Phase 3 |
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 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 : | October 2020 |
| Estimated Study Completion Date : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Proactive cytoreductive surgery + HIPEC
Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes).
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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. |
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Active Comparator: Proactive cytoreductive surgery
Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).
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Procedure: Proactive cytoreductive surgery
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) |
- 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
- 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).
- 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).
- 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.
- HIPEC technique operating time [ Time Frame: 36 months after surgery ]Average operating time calculation.
- HIPEC technique length of hospital stay [ Time Frame: 36 months after surgery ]Average length of hospital stay calculation.
- HIPEC technique re-admission rate [ Time Frame: 36 months after surgery ]Average re-admission rate calculation.
- 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.
- 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.
- 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.
- 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.
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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 |
Inclusion Criteria:
- Male and female patients between the ages of 18 and 75 years;
- 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;
- 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;
- Metastatic extent: M0;
- Karnofsky index >70 or Performance status ≤2;
- Informed consent properly completed.
Exclusion Criteria:
- 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.
- Presence of unresectability criteria;
- 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.
- Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
- 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).
- Severely altered liver, kidney and cardiovascular function;
- Intolerance to treatment;
- Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
- Pregnant or breastfeeding women.
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
| Contact: Antonio Miguel Luque Pineda | (+34) 957 011 040 | antonio.luque@imibic.org |
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| Principal Investigator: | Álvaro Arjona Sánchez, MD | Hospital Universitario Reina Sofía |
| 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: | January 30, 2020 |
| Last Verified: | January 2020 |
| 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. |
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HIPEC |
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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 |