drugset / 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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-11-16
- Primary completion
- 2024-03
- Completion
- 2024-03
Outcome
Met primary endpoint
paper The 3-year LC rate was higher in the investigational group (97.6%) than in the comparator group (87.6%) (log-rank P = .03; PMID 37099280 ↗
paper the addition of HIPEC to complete surgical resection for locally advanced colon cancer improved the 3-year LC rate compared with surgery alone. PMID 37099280 ↗
Publications
- Arjona-Sanchez A, Gutierrez-Calvo A, Segura-Sampedro JJ, Morales R, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Bijelic L, 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, Rufian-Andujar B, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Vazquez-Borrego MC, Rufian-Pena S. Efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy for locally advanced colorectal cancer (HIPECT4): final analysis of randomized clinical trial. BJS Open. 2025 Mar 5;10(2):zrag002. doi: 10.1093/bjsopen/zrag002.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 30 mg/m2 | Other |