Clinical trial NCT02614534: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: HIPEC
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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.

Primary outcomes:
measure: Locoregional Control (LC)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months and 36 months after surgery
measure: Disease Free Survival
timeFrame: 12 months and 36 months after surgery
measure: Evaluation of the morbidity and mortality related with the treatment
timeFrame: 36 months after surgery
measure: HIPEC technique operating time
timeFrame: 36 months after surgery
measure: HIPEC technique length of hospital stay
timeFrame: 36 months after surgery
measure: HIPEC technique re-admission rate
timeFrame: 36 months after surgery
measure: HIPEC technique laparoscopic vs laparotomy approach
timeFrame: 36 months after surgery
measure: HIPEC technique open vs. closed HIPEC technique
timeFrame: 36 months after surgery
measure: Quality of life questionnaire QLQ-C30
timeFrame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
measure: Quality of life questionnaires QLQ-CR29
timeFrame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí. Moisès Broggi
state: Barcelona
city: Castellón De La Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria "Dr. Negrín"
state: Islas Canarias
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
state: Islas Canarias
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Álvaro Arjona Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arjona-Sanchez A, Barrios P, Boldo-Roda E, Camps B, Carrasco-Campos J, Concepcion Martin V, Garcia-Fadrique A, Gutierrez-Calvo A, Morales R, Ortega-Perez G, Perez-Viejo E, Prada-Villaverde A, Torres-Melero J, Vicente E, Villarejo-Campos P, Sanchez-Hidalgo JM, Casado-Adam A, Garcia-Martin R, Medina M, Caro T, Villar C, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Torres-Tordera E, Briceno-Delgado FJ, Rufian-Pena S. HIPECT4: 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. BMC Cancer. 2018 Feb 13;18(1):183. doi: 10.1186/s12885-018-4096-0.