A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer (DaRT-V)

CCTU- Cancer Theme

Status

Enrolling

Conditions

Vulvar Squamous Cell Carcinoma

Vulva Cancer

Vulva Cancer, Recurrent

Treatments

Radiation: DaRT Diffusing Alpha-emitters Radiation Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04761146

DaRT-V

Details and patient eligibility

About

An investigation to investigate the use of diffusing alpha-emitters radiation therapy (DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva.

Full description

Squamous cell carcinoma of the vulva is a rare cancer accounting for less than 1% of female cancers. The disease predominantly affects women over the age of 65 although the incidence in younger women is rising, a finding that has been attributed to the effect of increasing human papillomavirus (HPV) infection .

The standard treatment for the primary tumour is surgical excision with the aim of achieving a 1 cm clear margin on histopathology. This requires the surgeon to remove 1.5-2 cm of surrounding normal tissue to allow for shrinkage after tissue fixation. Depending on the size and location of the tumour, the surgical procedure could vary from a wide local excision to a radical vulvectomy, including excision of adjacent structures such as the clitoris, lower urethra or anus, and/or reconstructive surgery. Wound infection and breakdown are common short-term complications of radical vulva surgery. Long term consequences include functional, cosmetic, psychological and psychosexual sequelae, which can have a significant negative impact on quality of life.

Recurrence rates for vulva squamous cell carcinomas range from 15% to 33%. Local recurrence in the vulva is the most common site of relapse (70%) with the groin nodes affected in 24%, pelvic nodes in 16% and distant metastases in 19%. The treatment of choice for local recurrence is surgical excision and 5-year survival rates of up to 45% have been reported. However, patients can develop multiple recurrences over a period of time and the feasibility of surgery becomes increasingly more limited as more and more tissue is removed.

Brachytherapy is a form of radiotherapy where radiation sources are placed directly in contact with or into (interstitial) cancerous tissue. The radiation emitted has a short range in tissue and the brachytherapy dose distribution conforms tightly to the location of the sources with minimal dose to the surrounding healthy tissues.

Alpha Tau Medical Ltd. proposes a novel treatment for malignant tumours using intra-tumoural alpha radiation, which is delivered using the Alpha DaRT Device (Alpha DaRT applicator + Alpha DaRT seeds). The technique, known as Diffusing Alpha-emitters Radiation Therapy (DaRT), combines the advantages of conventional interstitial brachytherapy with the destructive power of alpha particles.

Enrollment

10 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly diagnosed or recurrent (local) vulva cancer with or without distant metastases
Histopathological confirmation of squamous cell carcinoma
Macroscopic tumour in situ (i.e. tumour not excised)
Age 18 years and over
ECOG performance status 0-2
Life expectancy more than 6 months
Willing and able to give written informed consent to participate
Measurable target according to RECIST v1.1
Tumour size ≤ 7 centimetres in the longest diameter
Target is technically amenable for full coverage by the DaRT seeds

Exclusion criteria

Non-squamous histology
Concomitant illnesses which may increase risk of radiation toxicity e.g. autoimmune diseases, vasculitis, etc.
Concomitant immunosuppressive and/or long-term corticosteroid treatment
Involvement in other studies that may affect evaluation of response or toxicity of DaRT in the past 30 days or 5 half-lives of the investigational product, whichever is longer
Pregnancy or breastfeeding
Women of child-bearing potential unwilling to use adequate contraception for the duration of the study and 6 months after completion (further details in CIP section 13)
Nodal recurrence without local recurrence
Previous diagnosis of other malignancy < 3 years of enrolment (excluding non-melanomatous skin cancer)
No concurrent chemotherapy
Patients who have received prior chemotherapy or targeted therapy require a 1-month washout before DaRT insertion
Requirement to start chemotherapy within 6 weeks of DaRT insertion