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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital de Sant Joan Despí. Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Locoregional Control (LC)
Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence
Time frame: 3 years
Overall survival
Evaluate the effect of the addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years overall survival rate (%OS).
Time frame: 12 months and 36 months after surgery
Disease Free Survival
Evaluate the effect of addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years disease free survival rate (% DFS).
Time frame: 12 months and 36 months after surgery
Evaluation of the morbidity and mortality related with the treatment
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.
Time frame: 36 months after surgery
HIPEC technique operating time
Average operating time calculation.
Time frame: 36 months after surgery
HIPEC technique length of hospital stay
Average length of hospital stay calculation.
Time frame: 36 months after surgery
HIPEC technique re-admission rate
Average re-admission rate calculation.
Time frame: 36 months after surgery
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Hospital Universitario de Gran Canaria "Dr. Negrín"
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Provincial de Castellón
Castellon, Castellón, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Torrecárdenas
Almería, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
...and 9 more locations
HIPEC technique laparoscopic vs laparotomy approach
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.
Time frame: 36 months after surgery
HIPEC technique open vs. closed HIPEC technique
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.
Time frame: 36 months after surgery
Quality of life questionnaire QLQ-C30
With this outcome it will be calculated the effect on the quality of life of patients using 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
Quality of life questionnaires QLQ-CR29
With this outcome it will be calculated the effect on the quality of life of patients using questionnaire 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