Clinical trial • Phase IV • Oncology
MITOMYCIN for Peritoneal metastases of colorectal cancer
Phase IV trial of MITOMYCIN for Peritoneal metastases of colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Peritoneal metastases of colorectal cancer
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-04-2024
- First CTIS Authorization Date
- 07-05-2024
Trial design
Group 1: complete surgical resection + HIPEC with Mitomycin-C; Group 2: complete surgical resection without HIPEC.-controlled Phase IV trial across 31 sites in Spain.
- Comparator
- Group 1: complete surgical resection + HIPEC with Mitomycin-C; Group 2: complete surgical resection without HIPEC.
- Target Sample Size
- 216
- Trial Duration For Participant
- 1095
Eligibility
Recruits 216 Persons deprived of liberty or under guardianship are explicitly excluded. The criteria also exclude those with inability to understand the nature of the intervention, the risks, benefits, expected evolution and need for periodic medical examinations (for geographical, social or psychological reasons). Informed consent is required: patients must receive information and sign the study-specific Informed Consent. Minors are excluded (Age > 18 years). No other vulnerable populations are selected in the CTIS record..
- Pregnancy Exclusion
- Pregnancy (or suspected pregnancy) or lactation period.
- Vulnerable Population
- Persons deprived of liberty or under guardianship are explicitly excluded. The criteria also exclude those with inability to understand the nature of the intervention, the risks, benefits, expected evolution and need for periodic medical examinations (for geographical, social or psychological reasons). Informed consent is required: patients must receive information and sign the study-specific Informed Consent. Minors are excluded (Age > 18 years). No other vulnerable populations are selected in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Histologically proven colon cancer, except those with signet ring cells (those with > 50% of the tumor composed of such cells, which only account for 1% of CRC).\n- Absence of current or previously treated extraperitoneal metastases, including distant adenopathies (retroperitoneal, mediastinal,...), liver metastases, or pulmonary metastases (ruled out by PET in case of doubt).\n- Synchronous or metachronous peritoneal carcinomatosis of mild or moderate extension, with a PCI ≤ 20 (APPENDIX I) (intraoperative evaluation).\n- Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative evaluation).\n- Treatment with perioperative systemic chemotherapy (before and/or after the surgical procedure).\n- Age > 18 years.\n- Acceptable anesthetic/surgical risk: ASA 1-3 (APPENDIX II), ECOG 0-1 (APPENDIX III), hematological, renal and hepatic function without severe alterations (operable patients).\n- Information to the patient and signature of the study-specific Informed Consent."}
Exclusion criteria
- {"criterion_text":"- Peritoneal carcinomatosis of any other origin, in particular rectal cancer or appendiceal adenocarcinoma, or signet ring cell colon cancer on histology.\n- Urgent intervention for obstruction or perforation of a primary tumor with synchronous MP (although salvage or secondary CR + HIPEC after emergency surgery of the primary tumor are acceptable if the inclusion criteria are met).\n- Persons deprived of liberty or under guardianship.\n- Inability to understand the nature of the intervention, the risks, benefits, expected evolution and need to undergo periodic medical examinations, either for geographical, social or psychological reasons.\n- No intraoperative confirmation of peritoneal disease (PCI 0). Cases of perianastomotic (local) or lymph node (locoregional) recurrence will also be excluded.\n- High volume peritoneal carcinomatosis, with a PCI > 20 (APPENDIX I), or incomplete cytoreduction (intraoperative evaluation).\n- Concurrent or previously treated extraperitoneal disease.\n- Progression during preoperative chemotherapy, if received.\n- Patients previously treated with HIPEC.\n- History of other cancers (except cutaneous basal cell carcinoma or carcinoma in situ of the cervix) in the 5 years prior to study entry.\n- Patient included in another first-line clinical trial for the disease studied.\n- Pregnancy (or suspected pregnancy) or lactation period."}
Endpoints
Primary endpoints
- {"endpoint_text":"- peritoneal recurrence-free survival at 1, 2 and 3 years.","definition_or_measurement_approach":"Assessed at 1, 2 and 3 years (peritoneal recurrence-free survival at 1, 2 and 3 years)."}
Secondary endpoints
- {"endpoint_text":"- Overall recurrence (ORS) at 1, 2 and 3 years.","definition_or_measurement_approach":"Assessed at 1, 2 and 3 years."}
- {"endpoint_text":"- Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years.","definition_or_measurement_approach":"Assessed at 1, 2 and 3 years."}
- {"endpoint_text":"- Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC.","definition_or_measurement_approach":"Postoperative complications graded using CTCAE v5.0 at 90 days, including HIPEC-related events."}
- {"endpoint_text":"- Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression.","definition_or_measurement_approach":"Evaluation of listed prognostic factors as specified in protocol; PCI is stratified (1-10, 11-15, 16-20)."}
- {"endpoint_text":"- Overall survival at 1, 2 and 3 years.","definition_or_measurement_approach":"Assessed at 1, 2 and 3 years."}
- {"endpoint_text":"- Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times.","definition_or_measurement_approach":"Quality of life assessed with EORTC QLQ-C30 and QLQ-CR29 at specified time points."}
- {"endpoint_text":"- Correlation surgical PCI - pathological PCI","definition_or_measurement_approach":"Correlation analysis between surgical PCI and pathological PCI as stated."}
Recruitment
- Planned Sample Size
- 216
- Recruitment Window Months
- 59
- Consent Approach
- Study-specific informed consent is required; patients must receive information and sign the study-specific Informed Consent. Only adults (>18 years) are eligible so no assent for minors. A subject information and informed consent form document is listed in the CTIS documents; languages are not specified in the CTIS record.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 216
Spain
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 12-12-2024
- Processing Time Days
- 275
- Number Of Sites
- 31
- Number Of Participants
- 216
Sites
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Cirugía
- Principal Investigator Name
- Luis Gomez-Quiles
- Principal Investigator Email
- luisgomezquiles171261@gmail.com
- Contact Person Name
- Luis Gomez-Quiles
- Contact Person Email
- luisgomezquiles171261@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cirugía
- Principal Investigator Name
- Mª Eugenia Barrios Carvajal
- Principal Investigator Email
- barriosmariu@gmail.com
- Contact Person Name
- Mª Eugenia Barrios Carvajal
- Contact Person Email
- barriosmariu@gmail.com
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Cirugía
- Principal Investigator Name
- Manuel Emilio Marcello Fernandez
- Principal Investigator Email
- manuelemilio.marcello@salud.madrid.org
- Contact Person Name
- Manuel Emilio Marcello Fernandez
- Contact Person Email
- manuelemilio.marcello@salud.madrid.org
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Cirugía
- Principal Investigator Name
- Pedro Antonio Parra Baños
- Principal Investigator Email
- pedroapb@yahoo.es
- Contact Person Name
- Pedro Antonio Parra Baños
- Contact Person Email
- pedroapb@yahoo.es
- Site Name
- University Hospital Son Espases
- Department Name
- Cirugía
- Principal Investigator Name
- Rafael Morales Soriano
- Principal Investigator Email
- rafa.morales@telefonica.net
- Contact Person Name
- Rafael Morales Soriano
- Contact Person Email
- rafa.morales@telefonica.net
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- Cirugía
- Principal Investigator Name
- Juan Torres Melero
- Principal Investigator Email
- juantorresmelero@gmail.com
- Contact Person Name
- Juan Torres Melero
- Contact Person Email
- juantorresmelero@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cirugía
- Principal Investigator Name
- Mª Isabel Prieto Nieto
- Principal Investigator Email
- iprieto@intermic.com
- Contact Person Name
- Mª Isabel Prieto Nieto
- Contact Person Email
- iprieto@intermic.com
- Site Name
- Hospital Universitario Infanta Elena
- Department Name
- Cirugía
- Principal Investigator Name
- Cristina Rihuete Caro
- Principal Investigator Email
- crisrihuete@gmail.com
- Contact Person Name
- Cristina Rihuete Caro
- Contact Person Email
- crisrihuete@gmail.com
- Site Name
- Hospital De Sant Joan Despi Moisés Broggi
- Department Name
- Cirugía
- Principal Investigator Name
- Lana Bijelic
- Principal Investigator Email
- lana.bijelic@csi.cat
- Contact Person Name
- Lana Bijelic
- Contact Person Email
- lana.bijelic@csi.cat
- Site Name
- Hospital General Universitario Reina Sofia (Córdoba)
- Department Name
- Cirugía
- Principal Investigator Name
- Álvaro Arjona
- Principal Investigator Email
- alvaroarjona@hotmail.com
- Contact Person Name
- Álvaro Arjona
- Contact Person Email
- alvaroarjona@hotmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cirugía
- Principal Investigator Name
- Pedro Antonio Cascales
- Principal Investigator Email
- cascalescirugia@gmail.com
- Contact Person Name
- Pedro Antonio Cascales
- Contact Person Email
- cascalescirugia@gmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Cirugía
- Principal Investigator Name
- Manuel Artiles
- Principal Investigator Email
- martilesarmas@gmail.com
- Contact Person Name
- Manuel Artiles
- Contact Person Email
- martilesarmas@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Cirugía
- Principal Investigator Name
- Javier Vaqué Urbaneja
- Principal Investigator Email
- fjvaque@yahoo.es
- Contact Person Name
- Javier Vaqué Urbaneja
- Contact Person Email
- fjvaque@yahoo.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Cirugía
- Principal Investigator Name
- Daniel Díaz Gómez
- Principal Investigator Email
- daniel.diaz.gomez.sspa@juntadeandalucia.es
- Contact Person Name
- Daniel Díaz Gómez
- Contact Person Email
- daniel.diaz.gomez.sspa@juntadeandalucia.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Cirugía
- Principal Investigator Name
- Alfonso García Fadrique
- Principal Investigator Email
- agarciafadrique@gmail.com
- Contact Person Name
- Alfonso García Fadrique
- Contact Person Email
- agarciafadrique@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Cirugía
- Principal Investigator Name
- Luis González Bayón
- Principal Investigator Email
- lgbayon@salud.madrid.org
- Contact Person Name
- Luis González Bayón
- Contact Person Email
- lgbayon@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Cirugía
- Principal Investigator Name
- Joaquin Carrasco
- Principal Investigator Email
- joakicc@hotmail.com
- Contact Person Name
- Joaquin Carrasco
- Contact Person Email
- joakicc@hotmail.com
- Site Name
- Hospital Universitario Donostia
- Department Name
- Cirugía
- Principal Investigator Name
- Xabier Arteaga Martín
- Principal Investigator Email
- xabiarteaga@gmail.com
- Contact Person Name
- Xabier Arteaga Martín
- Contact Person Email
- xabiarteaga@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Cirugía
- Principal Investigator Name
- Pedro Villarejo Campos
- Principal Investigator Email
- villarejocampos@yahoo.es
- Contact Person Name
- Pedro Villarejo Campos
- Contact Person Email
- villarejocampos@yahoo.es
- Site Name
- Hospital Universitario De Fuenlabrada
- Department Name
- Cirugía
- Principal Investigator Name
- Fernando Pereira
- Principal Investigator Email
- fernando.pereira@salud.madrid.org
- Contact Person Name
- Fernando Pereira
- Contact Person Email
- fernando.pereira@salud.madrid.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cirugía
- Principal Investigator Name
- Julio Galindo Álvarez
- Principal Investigator Email
- julio.galindo@uah.es
- Contact Person Name
- Julio Galindo Álvarez
- Contact Person Email
- julio.galindo@uah.es
- Site Name
- MD Anderson Cancer Center (Madrid)
- Department Name
- Cirugía
- Principal Investigator Name
- Santiago González Moreno
- Principal Investigator Email
- sgonzalez@mdanderson.es
- Contact Person Name
- Santiago González Moreno
- Contact Person Email
- sgonzalez@mdanderson.es
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Cirugía
- Principal Investigator Name
- Isabel Jaén Torrejimeno
- Principal Investigator Email
- isabel.jaen@salud-juntaex.es
- Contact Person Name
- Isabel Jaén Torrejimeno
- Contact Person Email
- isabel.jaen@salud-juntaex.es
- Site Name
- Hospital Universitario Rio Hortega
- Department Name
- Cirugía
- Principal Investigator Name
- Enrique Asensio
- Principal Investigator Email
- easensiodi@saludcastillayleon.es
- Contact Person Name
- Enrique Asensio
- Contact Person Email
- easensiodi@saludcastillayleon.es
- Site Name
- Hospital General Universitario De Ciudad Real
- Department Name
- Cirugía
- Principal Investigator Name
- Susana Sánchez García
- Principal Investigator Email
- ssanchezgarcia15@gmail.com
- Contact Person Name
- Susana Sánchez García
- Contact Person Email
- ssanchezgarcia15@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Cirugía
- Principal Investigator Name
- Alicia Calero Amaro
- Principal Investigator Email
- alidoc20@yahoo.es
- Contact Person Name
- Alicia Calero Amaro
- Contact Person Email
- alidoc20@yahoo.es
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Cirugía
- Principal Investigator Name
- Estrella Turienzo
- Principal Investigator Email
- estrella.turienzo@gmail.com
- Contact Person Name
- Estrella Turienzo
- Contact Person Email
- estrella.turienzo@gmail.com
- Site Name
- Hospital Universitario Principe De Asturias
- Department Name
- Cirugía
- Principal Investigator Name
- Alberto Gutiérrez Calvo
- Principal Investigator Email
- alberto.gutierrez@salud.madrid.org
- Contact Person Name
- Alberto Gutiérrez Calvo
- Contact Person Email
- alberto.gutierrez@salud.madrid.org
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Cirugía
- Principal Investigator Name
- César Ramírez Plaza
- Principal Investigator Email
- cprptot@gmail.com
- Contact Person Name
- César Ramírez Plaza
- Contact Person Email
- cprptot@gmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Cirugía
- Principal Investigator Name
- Vicente Borrego Estella
- Principal Investigator Email
- vicenteborregoestella@gmail.com
- Contact Person Name
- Vicente Borrego Estella
- Contact Person Email
- vicenteborregoestella@gmail.com
- Site Name
- Consorcio Hospitalario Provincial De Castellon
- Department Name
- Cirugía
- Principal Investigator Name
- Enrique Boldó Roda
- Principal Investigator Email
- eboldo@aecirujanos.es
- Contact Person Name
- Enrique Boldó Roda
- Contact Person Email
- eboldo@aecirujanos.es
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario De Fuenlabrada
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Mitomicina Accord 40 mg polvo para solución inyectable y para perfusión EFG
- Active Substance
- MITOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAPERITONEAL USE
- Route
- Intraperitoneal
- Authorisation Status
- Marketing authorised (marketing authorisation number 82516)
- Maximum Dose
- 40 mg
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