- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04761146
A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer (DaRT-V)
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Urology, Haematology and Medical Devices Team Clinical Trials Unit - Cancer Theme
- Phone Number: 01223216083
- Email: cctuc@addenbrookes.nhs.uk
Study Locations
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Cambridgehire
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Cambridge, Cambridgehire, United Kingdom, CB20QQ
- Recruiting
- Cambridge University Hospitals NHSFT
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Contact:
- Li Tee Tan, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DaRT Diffusing Alpha-emitters Radiation Therapy
DaRT Diffusing Alpha-emitters Radiation Therapy using the DaRT applicator and seeds, inserted for 14 days prior to removal.
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DaRT is a brachytherapy treatment comprising stainless-steel 316LVM wires coated with radium-224 (Alpha DaRT seeds).
The radioactive seeds are inserted directly into the tumour on the perineum and will be removed after 14 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the feasibility of DaRT by the safety of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 6 months
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Measuring the feasibility of using the device by the treatment-related adverse events in the follow-up period (graded 1 'not significant' to 5 'death' with Common Terminology Criteria for Adverse Events v5.0)
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: Day 28 (4 weeks)
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Tumour response at 4 weeks (Day 28) after DaRT insertion as assessed by Response Evaluation Criteria in Solid Tumours (RECIST, complete response to progressive disease) criteria
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Day 28 (4 weeks)
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To evaluate the effect DaRT on the immunological response
Time Frame: 4-6 weeks
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Histological evidence of necrosis in pathological lymph nodes if removed.
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4-6 weeks
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Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 6 months
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Local control rate at 3-month and 6-month follow-up visits
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6 months
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Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 6 months
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Patient numerical rating scale (NRS) pain score, '0' representing "no pain" to '10' representing "extreme pain"
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6 months
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Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 6 months
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Patient mental state using the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire.
Scored 1-4 from 'Not at All' to 'Very Much'
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6 months
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Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 4-6 weeks
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Percentage of necrotic tissue if residual tumour is removed surgically
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4-6 weeks
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Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Time Frame: 6 months
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Patients physical state using the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire.
Scored 1-4 from 'Not at All' to 'Very Much'
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Li Tee Tan, Cambridge University Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Neoplasms, Squamous Cell
- Vulvar Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Carcinoma, Squamous Cell
- Vulvar Neoplasms
Other Study ID Numbers
- DaRT-V
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvar Squamous Cell Carcinoma
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage III Vulvar Cancer | Stage IVB Vulvar Cancer | Vulvar Squamous Cell CarcinomaUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Vulvar Squamous Cell Carcinoma | Stage IVA Vulvar Cancer AJCC v7United States
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TransgenePfizer; EMD Serono Research & Development Institute, Inc.; Merck KGaA, Darmstadt...Active, not recruitingHPV-Related Carcinoma | HPV-Related Cervical Carcinoma | HPV-Related Anal Squamous Cell Carcinoma | HPV-Related Penile Squamous Cell Carcinoma | HPV-Related Vulvar Squamous Cell CarcinomaUnited States, France, Spain
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Centre Hospitalier Universitaire de NiceTerminatedVulvar Intraepithelial Neoplasia | Vulvar Mucosa LesionsFrance
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