Clinical trial · Interventional
A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer
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
NCT04761146CI-TRIAL-00066697DaRT-VunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulva Cancer | — | UNRESOLVED | — |
| Vulva Cancer, Recurrent | — | UNRESOLVED | — |
| Vulvar Squamous Cell Carcinoma | Vulvar Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DaRT Diffusing Alpha-emitters Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Radiation: DaRT Diffusing Alpha-emitters Radiation Therapy
Primary outcomes (1)
- measure
- Assess the feasibility of DaRT by the safety of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
- timeFrame
- 6 months
- description
- 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)
Secondary outcomes (7)
- measure
- Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.