Huang Y, Alzahrani NA, Liauw W, Traiki TB, Morris DL Early Postoperative Intraperitoneal Chemotherapy for Low-Grade Appendiceal Mucinous Neoplasms with Pseudomyxoma Peritonei: Is it Beneficial? Ann Surg Oncol. 2017 Jan;24(1):176-183. doi: 10.1245/s10434-016-5529-0. Epub 2016 Oct 7.
Oman M, Lundqvist S, Gustavsson B, Hafstrom LO, Naredi P Phase I/II trial of intraperitoneal 5-Fluorouracil with and without intravenous vasopressin in non-resectable pancreas cancer. Cancer Chemother Pharmacol. 2005 Dec;56(6):603-9. doi: 10.1007/s00280-005-1012-5. Epub 2005 Jul 27.
Pestieau SR, Schnake KJ, Stuart OA, Sugarbaker PH Impact of carrier solutions on pharmacokinetics of intraperitoneal chemotherapy. Cancer Chemother Pharmacol. 2001 Mar;47(3):269-76. doi: 10.1007/s002800000214.
Soucisse ML, Liauw W, Hicks G, Morris DL Early postoperative intraperitoneal chemotherapy for lower gastrointestinal neoplasms with peritoneal metastasis: a systematic review and critical analysis. Pleura Peritoneum. 2019 Oct 4;4(3):20190007. doi: 10.1515/pp-2019-0007. eCollection 2019 Sep 1.
Thomas DM, Zalcberg JR 5-fluorouracil: a pharmacological paradigm in the use of cytotoxics. Clin Exp Pharmacol Physiol. 1998 Nov;25(11):887-95. doi: 10.1111/j.1440-1681.1998.tb02339.x.
Van der Speeten K, Govaerts K, Stuart OA, Sugarbaker PH Pharmacokinetics of the perioperative use of cancer chemotherapy in peritoneal surface malignancy patients. Gastroenterol Res Pract. 2012;2012:378064. doi: 10.1155/2012/378064. Epub 2012 Jun 13.
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
