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

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Brief Title

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

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

Brief 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.

Detailed 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.

Study Type


Primary Outcome

Assess the feasibility of DaRT by the safety of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Secondary Outcome

 Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva


Vulva Cancer, Recurrent


DaRT Diffusing Alpha-emitters Radiation Therapy

Study Arms / Comparison Groups

 DaRT Diffusing Alpha-emitters Radiation Therapy
Description:  DaRT Diffusing Alpha-emitters Radiation Therapy using the DaRT applicator and seeds, inserted for 14 days prior to removal.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 1, 2021

Completion Date

May 1, 2023

Primary Completion Date

November 1, 2022

Eligibility Criteria

        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

          -  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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Li Tee Tan, 01223216083, cctuc[email protected]

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

CCTU- Cancer Theme


 Alpha Tau Medical LTD.

Study Sponsor

Li Tee Tan, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust

Verification Date

February 2021