Dataset Information

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

ABSTRACT: This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.

DISEASE(S): Stage Iva Colorectal Cancer Ajcc V8,Stage Iva Uterine Corpus Cancer Ajcc V8,Postneoadjuvant Therapy Stage Iv Gastric Cancer Ajcc V8,Clinical Stage Ivb Gastric Cancer Ajcc V8,Malignant Uterine Neoplasm,Metastatic Malignant Solid Neoplasm,Carcinoma,Metastatic Appendix Carcinoma,Stage Ivc Appendix Carcinoma Ajcc V8,Stage Iv Appendix Carcinoma Ajcc V8,Metastatic Colorectal Carcinoma,Peritoneal Carcinomatosis,Neoplasms,Appendiceal Neoplasms,Stage Ivb Colorectal Cancer Ajcc V8,Stage Iv Ovarian Cancer Ajcc V8,Stage Ivb Ovarian Cancer Ajcc V8,Metastatic Malignant Neoplasm In The Peritoneum,Colorectal Neoplasms,Ovarian Neoplasms,Stomach Neoplasms,Clinical Stage Iva Gastric Cancer Ajcc V8,Clinical Stage Iv Gastric Cancer Ajcc V8,Stage Iv Uterine Corpus Cancer Ajcc V8,Stage Ivc Colorectal Cancer Ajcc V8,Stage Iv Colorectal Cancer Ajcc V8,Metastatic Ovarian Carcinoma,Stage Ivb Uterine Corpus Cancer Ajcc V8,Stage Iva Appendix Carcinoma Ajcc V8,Metastatic Gastric Carcinoma,Pathologic Stage Iv Gastric Cancer Ajcc V8,Peritoneal Neoplasms,Uterine Neoplasms,Stage Iva Ovarian Cancer Ajcc V8,Carcinoma, Ovarian Epithelial,Stage Ivb Appendix Carcinoma Ajcc V8

PROVIDER: 2334713 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This is a Phase I study designed to assess the safety of a novel intraperitoneal lignocaine eluting device following colon surgery. The participants will have a local anaesthetic implant placed via a laparoscopic port into the abdominal cavity at the end of the surgical procedure. The dose administered will be determined by the length of the lignocaine eluting device, which will be based on individual patient s ideal body weight. Our lignocaine eluting device has 16.1 mg lidocaine per cm of co-extrudate, which converts to 1.61g/metre. Our previous randomized controlled trial comparing intraperitoneal and intravenous lignocaine for pain relief following colectomy used a continual infusion dose of 1.5mg/kg/hour. We will use this same dose, but this calculation is complicated by the fact that our lignocaine eluting device will release more lignocaine at the start of the 72 hour period compared to the end of the 72 hour period. We estimate 40% of the drug load is released over 24 hours and 65% of the drug load is released over 48 hours. At 72 hours the implant will be removed on the ward by the investigator. Post-operative care will be standardised based on an established Enhanced Recovery After Surgery (ERAS) protocol. This involves a standardised multimodal pain protocol whereby patients self-administer opioids based on their pain levels, via a patient-controlled analgesia device. Primary outcome(s): The primary outcome is frequency of adverse effects and complications related, or possibly related, to the lignocaine eluting intraperitoneal device. Data will be extracted from consenting patient’s medical records. These will be graded in terms of severity in accordance with the Clavien Dindo classification for surgical complications. [ Adverse effects and complications following a 72 hour postoperative period.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety

Dataset Information

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

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