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

Phase 3

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: MITOMYCIN-C 30 mg; Procedure: Proactive cytoreductive surgery

• Registration Number: NCT02614534
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-11-09
• Study Start: 2015-11-16
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-25
• Status Verified: 2022-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive cytoreductive surgery + HIPEC	MITOMYCIN-C 30 mg	Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes).
Proactive cytoreductive surgery	Proactive cytoreductive surgery	Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).

Primary Outcome Measures

Name	Time	Method
Locoregional Control (LC)	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

Name	Time	Method
Disease Free Survival	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).
Quality of life questionnaires QLQ-CR29	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.
HIPEC technique open vs. closed HIPEC technique	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 operating time	36 months after surgery	Average operating time calculation.
Overall survival	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).
Evaluation of the morbidity and mortality related with the treatment	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 length of hospital stay	36 months after surgery	Average length of hospital stay calculation.
HIPEC technique re-admission rate	36 months after surgery	Average re-admission rate calculation.
HIPEC technique laparoscopic vs laparotomy approach	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	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.

Trial Locations

Locations (19)

Hospital de Sant Joan Despí. Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Islas Baleares, Spain

Hospital Universitario Torrecárdenas; 🇪🇸 Almería, Spain

Hospital Provincial de Castellón; 🇪🇸 Castellón De La Plana, Castellón, Spain

Hospital Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz De Tenerife, Islas Canarias, Spain

Hospital Universitario Príncipe de Asturias; 🇪🇸 Alcalá De Henares, Madrid, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

MD Anderson Cancer Center; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario HM Sanchinarro; 🇪🇸 Madrid, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital General Universitario Reina Sofía; 🇪🇸 Murcia, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario de Gran Canaria "Dr. Negrín"; 🇪🇸 Las Palmas De Gran Canaria, Islas Canarias, Spain