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Neoadjuvant DaRT for Locally Advanced Oral Cavity SCC

ConditionsSquamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the oral cavity (no involvement of the lips);

T1-T2, N1-N2; T3 N0-2 with T3 <5 cm, depth of infiltration <15 mm, (AJCC version 8 oral cavity);

Tumor must be potentially curable by conventional methods;

Primary tumor must be amenable for complete coverage (including margins) by the DaRT seeds;

Disqualifiers

Floor-of-mouth primaries or extension onto the floor-of-mouth;

Documented evidence of distant metastases (M1) based on a diagnostic, contrast-enhanced whole-body PET-CT scan ;

Any previous anti-cancer therapy for HNSCC (surgery, chemo, radiotherapy or molecularly targeted therapy);

Malignancy treated with curative intent and with no known active disease ≥2 years before enrolment and of low potential risk for recurrence

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT

    Device

    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.

Treatment groups

79 Participants
are divided into 1 treatment group
Group A: DaRT seedsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major Pathological Response (MPR)

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

Time frame
Day 30 (+5)

Secondary outcomes

1

Pathological Response

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

Time frame
Day 30 (+5)
2

Radiological Response

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.

Time frame
Day 30 (+5)
3

Metabolic Response

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.

Time frame
Day 30 (+5)
4

Overall Survival (OS)

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

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alpha Tau Medical LTD.

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: