NCT05065346

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2021-10-04
• Last updated: 2024-05-17

Locations

1 site across 1 country: Israel