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Radiation

DaRT Seeds for Skin Cancer

N/A

Recruiting

Research Sponsored by Alpha Tau Medical LTD.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor size ≤7 cm, at the longest diameter.

Single lesion per subject.

Must not have

Distant or nodal metastatic disease (according to the TNM [tumor, nodes , and metastases] staging system - N+ or M1 patients are excluded).

T4 disease or perineural spread of disease

Timeline

Screening 1 day

Treatment 12 months

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment called DaRT. The goal is to find out how well it works and how safe it is.

Who is the study for?

This trial is for adults over 18 with recurrent skin cancer (cutaneous Squamous Cell Carcinoma) that's not treatable by surgery or standard radiation. Participants must have tried at least one standard treatment, be in fairly good health with a life expectancy of more than a year, and able to undergo CT scans. They should also agree to use effective birth control methods.

What is being tested?

The study tests DaRT seeds - a type of internal radiation therapy - on up to 86 patients across multiple centers. It aims to see how well the treatment works (measured by tumor response), how long it lasts, its safety profile, and effects on survival rates and quality of life.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with internal radiation therapy like DaRT may include localized skin reactions, discomfort at the implant site, fatigue, and potential damage to nearby healthy tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is 7 cm or smaller in its largest size.

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I have only one cancerous lesion.

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My cancer can be fully treated with DaRT seeds without affecting vital organs.

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I can take care of myself but might not be able to do heavy physical work.

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I am willing and able to sign the Informed Consent form.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has not spread to distant organs or lymph nodes.

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My cancer has spread deeply or to nerves.

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I have skin cancer that has not been treated and needs surgery or radiation.

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My cancer is located in the mucosal, vulvar, anal, or penile areas.

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My cancer cannot be fully treated with DaRT seeds.

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DaRT seeds cannot be placed in my tumor due to its location near bones or vital organs.

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I am currently receiving or have received chemotherapy or biological therapy for cancer.

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I have not received any live vaccines in the last 30 days.

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My largest tumor is bigger than 7 cm.

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My tumor is identified as keratoacanthoma type.

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I do not have serious heart conditions like severe heart failure or recent heart attack.

Timeline

Screening ~ 1 day15 visits

Treatment ~ 12 months15 visits

Follow Up ~ 12 months12 visits

Screening ~ 1 day

Treatment ~ 12 months

Follow Up ~12 months

This trial's timeline: 1 day for screening, 12 months for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Response

Objective Response Rate

Secondary study objectives

DaRT-related Adverse Events

Overall Duration of Response (O-DOR)

Overall Survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DaRT seedsExperimental Treatment1 Intervention

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.

0 / 17Eligibility criteria met