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
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
1 other identifier
interventional
200
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 colorectal-cancer
Started Nov 2015
Longer than P75 for phase_3 colorectal-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedStudy Start
First participant enrolled
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 28, 2023
September 1, 2022
8.3 years
November 9, 2015
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Overall survival
12 months and 36 months after surgery
Disease Free Survival
12 months and 36 months after surgery
Evaluation of the morbidity and mortality related with the treatment
36 months after surgery
HIPEC technique operating time
36 months after surgery
HIPEC technique length of hospital stay
36 months after surgery
- +5 more secondary outcomes
Study Arms (2)
Proactive cytoreductive surgery + HIPEC
EXPERIMENTALTumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes).
Proactive cytoreductive surgery
ACTIVE COMPARATORTumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital de Sant Joan Despí. Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Hospital Universitario de Gran Canaria "Dr. Negrín"
Las Palmas de Gran Canaria, Canary Islands, 35019, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital Provincial de Castellón
Castellon, Castellón, 12002, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario Torrecárdenas
Almería, 04009, Spain
Hospital Universitario de Badajoz
Badajoz, 06080, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital General Universitario Reina Sofía
Murcia, 30003, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Related Publications (2)
Arjona-Sanchez A, Espinosa-Redondo E, Gutierrez-Calvo A, Segura-Sampedro JJ, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Barrios-Sanchez P, Torres-Melero J, Ramirez Faraco M, Prada-Villaverde A, Carrasco-Campos J, Artiles-Armas M, Villarejo-Campos P, Ortega-Perez G, Boldo-Roda E, Sanchez-Hidalgo JM, Casado-Adam A, Rodriguez-Ortiz L, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Briceno-Delgado J, Rufian-Pena S; Grupo Espanol de Carcinomatosis Peritoneal. Efficacy and Safety of Intraoperative Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Colon Cancer: A Phase 3 Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):683-691. doi: 10.1001/jamasurg.2023.0662.
PMID: 37099280DERIVEDArjona-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.
PMID: 29439668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Álvaro Arjona Sánchez, MD
Hospital Universitario Reina Sofía
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 25, 2015
Study Start
November 16, 2015
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
September 28, 2023
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.