Phase
Condition
Colon Cancer
Carcinoma
Abdominal Cancer
Treatment
complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes
complete cytoreductive surgery without HIPEC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with > 50% of the tumor composed of these cells, which comprise only 1% ofall colon adenocarcinomas).
Absence of previously treated or current extraperitoneal metastases, includingdistant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, orlung metastases (ruled out by PET-scan in case of doubt).
Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with aPCI ≤ 20 (Appendix 2) (intraoperative confirmation).
Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).
Treatment with perioperative systemic chemotherapy (SCT), before and/or aftersurgical procedure.
Age> 18 years.
Acceptable anesthetic/surgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). Nosevere alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).
Information to the patient and signing of a study-specific informed consent.
Exclusion
Exclusion Criteria:
Peritoneal carcinomatosis of any other origin, particularly rectal cancer orappendicular adenocarcinoma, or signet ring cell colon cancer on histology.
No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases ofperianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
High volume peritoneal disease with a PCI> 20 (intraoperative evaluation).
Concurrent or previously treated extraperitoneal disease.
Disease progression during preoperative chemotherapy, if received.
Patients previously treated with HIPEC.
History of other cancers (except cutaneous basal cell carcinoma or cervix carcinomain situ) in the 5 years prior to entry into the study.
Patients included in another first-line clinical trial for the studied disease.
Pregnancy (or suspicion of it) or lactation period.
Emergency surgical intervention for obstruction or perforation of a primary tumourwith synchronous PM (although rescue and secondary CRS + HIPEC after emergencysurgery of the primary tumour are acceptable if inclusion criteria are fulfilled).
Persons deprived of liberty or under legal or administrative supervision.
Inability to understand the nature of the intervention, the risks, benefits,expected evolution and the need to undergo periodic medical examinations, either forgeographical, social or psychological reasons.
Study Design
Study Description
Connect with a study center
Hospital General Universitario de Elche
Elche, Alicante 03203
SpainActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainActive - Recruiting
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona 08970
SpainActive - Recruiting
Hospital General Universitario de Castellón
Castelló de la Plana, Castellón 12004
SpainActive - Recruiting
Consorcio Hospitalario Provincial de Castellón
Castellón De La Plana, Castellón 12006
SpainActive - Recruiting
Hospital Universitario Donostia
San Sebastián, Gipuzkoa 20014
SpainSite Not Available
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas De Gran Canaria, Gran Canaria 35010
SpainActive - Recruiting
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid 28805
SpainActive - Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid 28922
SpainActive - Recruiting
HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)
Fuenlabrada, Madrid 28942
SpainActive - Recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid 28340
SpainActive - Recruiting
Hospital Universitario Son Espases
Palma De Mallorca, Mallorca 07210
SpainActive - Recruiting
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia 30120
SpainActive - Recruiting
Hospital Universitario Torrecárdenas
Almería, 04009
SpainActive - Recruiting
Complejo Hospitalario Universitario de Badajoz
Badajoz, 6080
SpainActive - Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
SpainActive - Recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
SpainActive - Recruiting
Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Ramón Y Cajal
Madrid, 28034
SpainActive - Recruiting
Md Anderson Cancer Center
Madrid, 28033
SpainSite Not Available
Hospital General Universitario Reina Sofía
Murcia, 30003
SpainActive - Recruiting
Hospital Quirónsalud Málaga
Málaga, 29004
SpainSite Not Available
Hospital Regional Universitario de Málaga
Málaga, 29010
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
SpainActive - Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
SpainActive - Recruiting
Hospital Universitario Río Hortega
Valladolid, 47012
SpainActive - Recruiting
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, 50009
SpainActive - Recruiting
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