دورية أكاديمية
INTRAPERITONEAL CHEMOTHERAPY FOR GASTRIC CANCER WITH PERITONEAL CARCINOMATOSIS: STUDY PROTOCOL OF A PHASE II TRIAL.
العنوان: | INTRAPERITONEAL CHEMOTHERAPY FOR GASTRIC CANCER WITH PERITONEAL CARCINOMATOSIS: STUDY PROTOCOL OF A PHASE II TRIAL. |
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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. |
References: | J Gastrointest Oncol. 2016 Feb;7(1):29-44. (PMID: 26941982) Ann Surg. 1997 Mar;225(3):262-7. (PMID: 9060581) Gastric Cancer. 2017 Mar;20(Suppl 1):122-127. (PMID: 27766496) J Gastrointest Surg. 2006 Feb;10(2):170-6, discussion 176-7. (PMID: 16455447) Gastric Cancer. 2021 Jan;24(1):1-21. (PMID: 32060757) CA Cancer J Clin. 2021 May;71(3):209-249. (PMID: 33538338) Arq Bras Cir Dig. 2020 Dec 18;33(3):e1535. (PMID: 33331431) Ann Surg Oncol. 2017 Oct;24(11):3338-3344. (PMID: 28799004) Clinics (Sao Paulo). 2016 Dec 01;71(12):733-745. (PMID: 28076519) J Clin Med. 2021 Oct 23;10(21):. (PMID: 34768402) Arq Bras Cir Dig. 2019;32(2):e1435. (PMID: 31038560) Cancer. 2013 Sep 15;119(18):3354-8. (PMID: 23798046) Cancer Treat Res. 1996;82:359-74. (PMID: 8849962) Ann Surg Oncol. 2014 Feb;21(2):539-46. (PMID: 23975319) Cancer Lett. 2005 Jun 1;223(1):129-35. (PMID: 15890245) J Natl Compr Canc Netw. 2004 Nov;2(6):597-611. (PMID: 19780303) Cancer Sci. 2011 Jan;102(1):200-5. (PMID: 20942868) Arq Bras Cir Dig. 2020;33(2):e1514. (PMID: 32844884) World J Surg Oncol. 2019 Dec 11;17(1):215. (PMID: 31829265) J Surg Oncol. 2014 Sep;110(3):275-84. (PMID: 25042700) Cancer. 2002 Feb 1;94(3):641-6. (PMID: 11857295) Eur J Surg Oncol. 2021 Jan;47(1):123-127. (PMID: 32561204) J Clin Oncol. 2018 Jul 1;36(19):1922-1929. (PMID: 29746229) J Surg Oncol. 2014 Sep;110(3):291-7. (PMID: 24850538) Cancer. 2000 Jan 15;88(2):358-63. (PMID: 10640968) Gastric Cancer. 2017 Mar;20(Suppl 1):111-121. (PMID: 27803990) Gastric Cancer. 2005;8(3):142-8. (PMID: 16086116) Cancer Manag Res. 2019 May 02;11:3993-4003. (PMID: 31118812) BMC Cancer. 2019 May 6;19(1):420. (PMID: 31060544) Arq Bras Cir Dig. 2023 Jan 09;35:e1700. (PMID: 36629683) Ann Oncol. 2022 Oct;33(10):1005-1020. (PMID: 35914639) Arq Bras Cir Dig. 2022 Jun 17;35:e1648. (PMID: 35730877) Anticancer Res. 2012 Sep;32(9):4071-5. (PMID: 22993363) Clinics (Sao Paulo). 2018 Dec 10;73(suppl 1):e543s. (PMID: 30540120) Arq Bras Cir Dig. 2021 May 14;34(1):e1563. (PMID: 34008707) Ann Surg Oncol. 2011 Jun;18(6):1575-81. (PMID: 21431408) |
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 |
تدمد: | 2317-6326 |
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DOI: | 10.1590/0102-672020230026e1744 |