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

Colorectal Cancer Clinical Trial

— HIPECT4  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02614534
• Other study ID #: FCO-HIP-2015-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 16, 2015
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• MITOMYCIN-C 30 mg
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.

Procedure:
• Proactive cytoreductive surgery
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital Universitario Torrecárdenas	Almería
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Provincial de Castellón	Castellón De La Plana	Castellón
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Gran Canaria "Dr. Negrín"	Las Palmas De Gran Canaria	Islas Canarias
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital General Universitario Reina Sofía	Murcia
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital de Sant Joan Despí. Moisès Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife	Islas Canarias
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Instituto Valenciano de Oncología	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional Control (LC)	Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence	3 years
Secondary	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).	12 months and 36 months after surgery
Secondary	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).	12 months and 36 months after surgery
Secondary	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.	36 months after surgery
Secondary	HIPEC technique operating time	Average operating time calculation.	36 months after surgery
Secondary	HIPEC technique length of hospital stay	Average length of hospital stay calculation.	36 months after surgery
Secondary	HIPEC technique re-admission rate	Average re-admission rate calculation.	36 months after surgery
Secondary	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.	36 months after surgery
Secondary	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.	36 months after surgery
Secondary	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.	At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Secondary	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.	At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery