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Study protocol: phase 1 dose escalating study of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin in peritoneal metastasis.
Kim, Guowei; Tan, Hon Lyn; Chen, Elya; Teo, Siok Chin; Jang, Clarisse Jia Min; Ho, Jingshan; Ang, Yvonne; Ngoi, Natalie Yan Li; Chee, Cheng Ean; Lieske, Bettina; Shabbir, Asim; Wang, Ling-Zhi; So, Jimmy Bok Yan; Yong, Wei Peng.
Afiliación
  • Kim G; University Surgical Cluster, National University Health System, Singapore, Singapore.
  • Tan HL; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
  • Chen E; Department of Surgery, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, Singapore.
  • Teo SC; Department of Surgery, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, Singapore.
  • Jang CJM; Department of Surgery, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, Singapore.
  • Ho J; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
  • Ang Y; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
  • Ngoi NYL; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
  • Chee CE; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
  • Lieske B; University Surgical Cluster, National University Health System, Singapore, Singapore.
  • Shabbir A; University Surgical Cluster, National University Health System, Singapore, Singapore.
  • Wang LZ; Cancer Science Institute of Singapore, Singapore, Singapore.
  • So JBY; Department of Surgery, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, Singapore.
  • Yong WP; Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore.
Pleura Peritoneum ; 3(3): 20180118, 2018 Sep 01.
Article en En | MEDLINE | ID: mdl-30911663
BACKGROUND: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel laparoscopic intraperitoneal chemotherapy technique, with advantages such as homogeneous distribution of aerosol and deeper tissue penetration. Thus far, PIPAC oxaliplatin has been administered at an arbitrary dose of 92 mg/m2. AIM: We aim to determine the dose-related safety profile and tolerability of PIPAC oxaliplatin using an evidence-based approach. The secondary aim is to evaluate clinic-pathologic response and the pharmacokinetic profile. METHODS: This is a phase I 3+3 dose escalation study for gastric and colorectal cancer with predominant peritoneal metastasis starting at a dose of 45 mg/m2. Safety is assessed according to Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (version 4.0). Clinico-pathologic response is assessed using the Peritoneal Regression Grading Score, Peritoneal Cancer Index, and Response Evaluation Criteria In Solid Tumour criteria (version 1.1). Pharmacokinetic analysis is performed using Inductively Coupled Plasma-Mass Spectrometry assay. This trial is registered on ClinicalTrials.gov (NCT03172416). CONCLUSIONS: This phase I study can provide the scientific basis to identify the optimal dose for PIPAC with oxaliplatin such that the benefits of this novel and promising intraperitoneal chemotherapy delivery technique can be maximized.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Pleura Peritoneum Año: 2018 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Alemania
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Pleura Peritoneum Año: 2018 Tipo del documento: Article País de afiliación: Singapur Pais de publicación: Alemania