Status:
UNKNOWN
A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer
Lead Sponsor:
CCTU- Cancer Theme
Collaborating Sponsors:
Alpha Tau Medical LTD.
Conditions:
Vulva Cancer, Recurrent
Vulvar Squamous Cell Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04761146
Start Date
February 28 2023
End Date
January 1 2026
Last Update
May 25 2023
Active Locations (1)
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1
Cambridge University Hospitals NHSFT
Cambridge, Cambridgehire, United Kingdom, CB20QQ