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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Directional Brachytherapy Source Implant
  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.

Первичные конечные точки

• Safety of CivaSheet Radiation Treatement [Срок оценки: 1 Year]

Вторичные конечные точки (4)

• Efficacy of CivaSheet Radiation Treatment [Срок оценки: 1 Year]
• Morbidity of patients following surgery and radiation [Срок оценки: 2 Year]
• Post Operative Radiation Dosimetry Calculation [Срок оценки: 1 Month]
• Length of Hospital Stay [Срок оценки: 1 Month]

Критерии участия

Критерии включения

• • Subject signed inform consent

• Age > 18 years
• Not pregnant or breast feeding
• Patient capable of undergoing anesthesia
• Patient selected to undergo Whipple procedure or distal pancreatectomy
• Patient does not have metastatic disease
• Patients will have close margins
• No prior radiation therapy to the region for separate cancer
• Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
• Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
• Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
• Gemcitabine + nb-paclitaxel
• FOLFIRINOX
• Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
• up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil

Критерии исключения

• Not surgical candidate
• Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
• An IRE candidate (IRE is Percutaneous irreversible electroporation)
• Recurrent or previously resected tumors
• Documented History of Alcoholism and or drug abuse
• Participant in other clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Tampa General Hospital — Tampa
• Rush University Cancer Center — Chicago
• Advocate Christ Medical Center — Oak Lawn
• University Medical Center LSU — New Orleans
• Fox Chase Cancer Center — Philadelphia
• Virginia Commonwealth University Massey Cancer Center — Richmond

Идентификаторы

NCT: NCT02843945 · CT004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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