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

Vulva Cancer Clinical Trial

Official title: A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters (DaRT) for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Vulva Cancer
• Vulva Cancer, Recurrent
• Vulvar Neoplasms
• Vulvar Squamous Cell Carcinoma

• NCT number: NCT04761146
• Study type: Interventional
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Urology, Haematology and Medical Devices Team Clinical Trials Un
• Phone: 01223216083
• Email: cctuc@addenbrookes.nhs.uk
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Completion date: January 1, 2026