دورية أكاديمية
أعرض في EDS

INTRAPERITONEAL CHEMOTHERAPY FOR GASTRIC CANCER WITH PERITONEAL CARCINOMATOSIS: STUDY PROTOCOL OF A PHASE II TRIAL.

التفاصيل البيبلوغرافية
العنوان: INTRAPERITONEAL CHEMOTHERAPY FOR GASTRIC CANCER WITH PERITONEAL CARCINOMATOSIS: STUDY PROTOCOL OF A PHASE II TRIAL.
المؤلفون: Ramos MFKP; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil., Pereira MA; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil., Charruf AZ; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil., Victor CR; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil., Gregorio JVAM; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil., Alban LBV; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil., Moniz CMV; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil., Zilberstein B; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil., Mello ES; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Pathology - São Paulo (SP), Brazil., Hoff PMG; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil., Ribeiro Junior U; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil., Dias AR; Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil.
المصدر: Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery [Arq Bras Cir Dig] 2023 Jul 17; Vol. 36, pp. e1744. Date of Electronic Publication: 2023 Jul 17 (Print Publication: 2023).
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: Colégio Brasileiro de Cirurgia Digestiva Country of Publication: Brazil NLM ID: 9100283 Publication Model: eCollection Cited Medium: Internet ISSN: 2317-6326 (Electronic) Linking ISSN: 01026720 NLM ISO Abbreviation: Arq Bras Cir Dig Subsets: MEDLINE
أسماء مطبوعة: Publication: São Paulo, Brasil : Colégio Brasileiro de Cirurgia Digestiva
Original Publication: São Paulo, Brasil : Disciplina de Cirurgia do Aparelho Digestivo do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo,
مواضيع طبية MeSH: Antineoplastic Combined Chemotherapy Protocols*/administration & dosage , Antineoplastic Combined Chemotherapy Protocols*/adverse effects , Peritoneal Neoplasms*/secondary , Peritoneal Neoplasms*/therapy , Stomach Neoplasms*/pathology , Stomach Neoplasms*/therapy, Adolescent ; Adult ; Aged ; Humans ; Middle Aged ; Young Adult ; Clinical Trials, Phase II as Topic ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; Prospective Studies
مستخلص: Background: Peritoneal carcinomatosis in gastric cancer is considered a fatal disease, without expectation of definitive cure. As systemic chemotherapy is not sufficient to contain the disease, a multimodal approach associating intraperitoneal chemotherapy with surgery may represent an alternative for these cases.
Aims: The aim of this study was to investigate the role of intraperitoneal chemotherapy in stage IV gastric cancer patients with peritoneal metastasis.
Methods: This study is a single institutional single-arm prospective clinical trial phase II (NCT05541146). Patients with the following inclusion criteria undergo implantation of a peritoneal catheter for intraperitoneal chemotherapy: Stage IV gastric adenocarcinoma; age 18-75 years; Peritoneal carcinomatosis with peritoneal cancer index<12; Eastern Cooperative Oncology Group 0/1; good clinical status; and lab exams within normal limits. The study protocol consists of four cycles of intraperitoneal chemotherapy with paclitaxel associated with systemic chemotherapy. After treatment, patients with peritoneal response assessed by staging laparoscopy undergo conversion gastrectomy.
Results: The primary outcome is the rate of complete peritoneal response. Progression-free and overall survivals are other outcomes evaluated. The study started in July 2022, and patients will be screened for inclusion until 30 are enrolled.
Conclusions: Therapies for advanced gastric cancer patients have been evaluated in clinical trials but without success in patients with peritoneal metastasis. The treatment proposed in this trial can be promising, with easy catheter implantation and ambulatory intraperitoneal chemotherapy regime. Verifying the efficacy and safety of paclitaxel with systemic chemotherapy is an important progress that this study intends to investigate.
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المشرفين على المادة: P88XT4IS4D (Paclitaxel)
تواريخ الأحداث: Date Created: 20230719 Date Completed: 20230725 Latest Revision: 20240327
رمز التحديث: 20240327
مُعرف محوري في PubMed: PMC10356002
DOI: 10.1590/0102-672020230026e1744
PMID: 37466566
قاعدة البيانات: MEDLINE
الوصف
تدمد:2317-6326
DOI:10.1590/0102-672020230026e1744