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

NCT02902107 | Completed Phase 1

• 1 other identifier: 16-605
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Malignancy; Pelvic Malignancy

Keywords

Low Dose Rate Brachytherapy; CivaSheet; 16-605

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

surgical resection and intraoperative radiation therapy (IORT)

EXPERIMENTAL

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.

Device: CivaSheet; Radiation: Brachytherapy; Procedure: surgical resection

Interventions

CivaSheet DEVICE

surgical resection and intraoperative radiation therapy (IORT)

Brachytherapy RADIATION

surgical resection and intraoperative radiation therapy (IORT)

surgical resection PROCEDURE

surgical resection and intraoperative radiation therapy (IORT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• CivaTech Oncology: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Abraham Wu, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: September 9, 2016
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

US (1)