Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet

Pelvic Malignancy Clinical Trial

Official title: A Pilot Feasibility Trial of Unidirectional Low Dose Rate Brachytherapy for Patients With Abdominal and Pelvic Malignancy Undergoing Surgical Resection Requiring Intraoperative Radiation Therapy

Status Active, not recruiting

Clinical Trial Summary

This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Abdominal Malignancy
• Neoplasms
• Pelvic Malignancy

• NCT number: NCT02902107
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 2016
• Completion date: September 2025