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Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT

Liron Dimnik

Aron Popovtzer, MD

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device (DaRT) as a treatment prior to additional radiation or chemo therapy.

The study is planned as a phase II, single arm interventional, open-label, multi-center, prospective study evaluating DaRT as a neoadjuvant therapy in patients with advanced oral cavity Squamous Cell Carcinoma.

The study will enroll 79 subjects with pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the oral cavity above the age of 18.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

The target lesion will be inserted with DaRT in a neo-adjuvant setting. DaRT seeds will be removed 15 days following the insertion. Surgery will follow 15 to 20 days after removal of the DaRT seeds followed by standard chemoradiotherapy or radiotherapy alone based on histopathology.

The primary outcome of the study will be the assessment of the major pathological response.

Neoadjuvant DaRT for Locally Advanced Oral Cavity SCC

A Study to Evaluate the Efficacy of Neoadjuvant DaRT for Locally Advanced Oral Cavity Squamous Cell Carcinoma

Assessment of the effect of neoadjuvant DaRT on Major Pathological Response following DaRT seeds insertion

Assessment of the effect of neoadjuvant DaRT on pathological response, using a four-point scale following DaRT seeds insertion

Assessment of the effect of neoadjuvant DaRT on radiological response, as measured by the overall response rate (ORR) of the primary tumor and nodes by RECIST 1.1 (based on CT). Each patient will be assigned one of the following categories based on local assessment: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death or not evaluable.

Assessment of the effect of neoadjuvant DaRT on radiological response, as measured by Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST - based on positron emission tomography (PET-CT)). Each patient will be assigned one of the following categories based on local assessment: complete metabolic response, partial metabolic response, stable metabolic disease, progressive metabolic disease, early death or not evaluable.

Defined as the time interval between the date of of DaRT seeds insertion and the date of death for any cause.

Defined as time from DaRT seeds insertion to date of first occurrence of any loco-regional progression or recurrence, metastatic progression, or death due to any cause, whichever comes first.

Measured by the incidence of all adverse events assessed according to CTCAE version 5

Each patient undergoing surgery will be assigned one of the following categories based on the margin in the primary specimen (final margin after resection, if any): positive margin, close margin, clear margin.

The Clavien-Dindo Classification of Surgical Complications (2009) will be used to grade the complications from I (any deviation from the normal post-operative course without the need for pharmaceutical treatment or surgical, endoscopic, and radiological interventions) to V (Death).

Spots Global Cancer Trial Database for radiation: diffusing alpha radiation emitters therapy (dart