Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Implanted with CivaSheet during tumor removal

Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence

CivaSheet

Carra Castagnero

Kristy Perez, PhD

Riley Sticca

Dian Wang, MD

Sara McCarney, BSN

Krisha Howell, MD

This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.

Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.

Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years

rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria

Rate of complications following device implant related or unrelated to the device

Amount of radiation dose delivered to the target volume and the adjacent organs at risk

CivaTech Oncology

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.

The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Directional Brachytherapy Source Implant

Kristy Perez

Zachary Miller

Colleen Valenti, OCN

Paul Crossan, MD

Marc Mesleh, MD

Joshua Meyer, MD

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Dose escalation Phase I followed by a feasibility trial in Phase II

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

Patients will be monitored for one year to determine the local cancer recurrence rate

2 year survival rates for patients post surgery and CivaSheet radiation treatment

Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory

Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.

Symptoms and General Pathology

Recurrence

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.

Brachytherapy

surgical resection

Abraham Wu, MD

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®	NCT04033081	Sarcoma	CivaSheet	-	CivaTech Oncology
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®	NCT04033081	Sarcoma	CivaSheet	-	CivaTech Oncology
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®	NCT04033081	Sarcoma	CivaSheet	-	CivaTech Oncology
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source	NCT02843945	Pancreatic Canc...	Directional Bra...	18 Years -	CivaTech Oncology
Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet	NCT02902107	Abdominal Malig... Pelvic Malignan...	CivaSheet Brachytherapy surgical resect...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for civasheet

Every month we try and update this database with for civasheet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for civasheet

Every month we try and update this database with for civasheet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for civasheet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.