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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Malignancy; Pelvic Malignancy
• Intervention / Treatment: Radiation: Brachytherapy; Procedure: surgical resection; Device: CivaSheet

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologic, cytologic, or radiologically evidence of locally advanced, residual or recurrent solid malignancy of the abdomen or pelvis requiring surgical resection
• Maximum projected treatment length 15cm and width 5cm, which are the dimensions of the largest available CivaSheet
• Medically fit and willing to undergo resection of disease
• Age ≥ 18 years
• ECOG performance status 0, 1, or 2
• ANC ≥ 1.5 cells/mm3, PLT≥100,000/mm3, PT/aPTT within normal limits at time of surgery
• Life expectancy, in the clinician's judgment, greater than 1 year.

Exclusion Criteria:

• Women who are pregnant
• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy after the receipt of brachytherapy. Male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy
• Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
• Patients who, in the investigator's judgment, are unwilling or unable to consent to and return for recommended post-treatment scans as outlined in this study.
• Patients on concurrent anti-cancer therapy, unless specifically agreed to by the patient's medical oncologist and consenting professional.
• Patients with contraindications to general anesthesia, as determined by the treating physician or surgeon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgical resection and intraoperative radiation therapy (IORT); Brachytherapy will be administered using the CivaSheet, a novel permanent LDR palladium-103 (Pd-103) planar brachytherapy device that is applied directly to the surgical resection bed.	Radiation: Brachytherapy; Procedure: surgical resection; Device: CivaSheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of successful implantation of the device in patients	Feasibility is determined by successful implantation of the device into a patient who has been enrolled on the protocol and deemed appropriate for IORT at the time of surgery.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: CivaTech Oncology
• Investigators: Principal Investigator: Abraham Wu, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CivaSheet; Low Dose Rate Brachytherapy; 16-605
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 16-605