Neoadjuvant DaRT for Locally Advanced Oral Cavity SCC

NCT05065346 | Not Yet Recruiting

• 1 other identifier: CTP-OCC-00
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma

Keywords

Oral Cavity Squamous Cell Carcinoma; Radiotherapy; Brachytherapy; Alpha Radiation

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR)

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

  Day 30 (+5)

Secondary Outcomes (8)

• Pathological Response

  Day 30 (+5)

• Radiological Response

  Day 30 (+5)

• Metabolic Response

  Day 30 (+5)

• Overall Survival (OS)

  Up to 24 months

• Disease Free Survival (DFS)

  Up to 24 months

Study Arms (1)

DaRT seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT

Interventions

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.

DaRT seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Assessment by a Multi-Disciplinary Team (MDT) of the treatment naïve patient and suitable for DaRT based on diagnostic, contrast enhanced whole body PET-CT - and MRI at the discretion of the investigator - within 2 weeks prior to enrolment. MDT preferably composed of a head and neck/ear, nose, and throat (ENT) surgeon, medical oncologist, radiologist, radiotherapist, and pathologist but at least a surgeon and a radiotherapist;
• Age 18 and older;
• Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) Performance status 0-2;
• Adequate bone marrow function as demonstrated by neutrophils (ANC) ≥ 1,5 109 /L, platelet count ≥ 100 109 /L, leukocytes (WBC) ≥ 3.0 109 /L;
• Hemoglobin ≥ 9.0 g/dL
• Calculated creatinine clearance (CL) \> 60 mL/min by the Cockcroft-Gault formula;
• Coagulation parameter (as per institution's standard international normalized ratio (INR), PT or Quick PT) is within the normal ranges, or within the expected target range of their current dose for those patients receiving anticoagulant therapy.
• Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 21 days prior to the DaRT insertion.
• Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.
• Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment.
• Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:

You may not qualify if:

• 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);
• History of another primary malignancy with the exception of:
• Malignancy treated with curative intent and with no known active disease ≥2 years before enrolment and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease;
• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study;
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial;
• Known contraindication to imaging tracer or nay product of contrast media, or MRI contraindications.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (1)

Sharett institute, Hadassah University Hospital - Ein-Kerem

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Aron Popovtzer, MD

  Sharett institute, Hadassah Medical Center - Ein-Kerem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972-2-373-7000; LironD@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: October 4, 2021
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

IL (1)