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

NCT04761146 | Unknown

• 1 other identifier: DaRT-V
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulva Cancer, Recurrent; Vulvar Squamous Cell Carcinoma; Vulva Cancer

Keywords

Medical Device; Brachytherapy; Diffusing Alpha-emitters

Outcome Measures

Primary Outcomes (1)

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

  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)

  6 months

Secondary Outcomes (7)

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

  Day 28 (4 weeks)

• To evaluate the effect DaRT on the immunological response

  4-6 weeks

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

  6 months

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

  6 months

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

  6 months

Study Arms (1)

DaRT Diffusing Alpha-emitters Radiation Therapy

EXPERIMENTAL

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

Radiation: DaRT Diffusing Alpha-emitters Radiation Therapy

Interventions

DaRT Diffusing Alpha-emitters Radiation Therapy RADIATION

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.

DaRT Diffusing Alpha-emitters Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility based on sex assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Alpha Tau Medical LTD.: collaborator

Study Sites (1)

Cambridge University Hospitals NHSFT

Cambridge, Cambridgehire, CB20QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Tee Tan

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urology, Haematology and Medical Devices Team Clinical Trials Unit - Cancer Theme

CONTACT

01223216083; cctuc@addenbrookes.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Li Tee Tan

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 18, 2021
• Study Start: February 28, 2023
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)