Using alpha radiation therapy to treat 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
This study is testing a new type of radiation therapy for vulva cancer to see if it can safely target tumors and reduce the need for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cambridge, Cambridgehire) |
| Trial ID | NCT04761146 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of diffusing alpha-emitters radiation therapy (DaRT) for treating new and recurrent squamous cell carcinoma of the vulva. The approach aims to provide a targeted treatment option that minimizes the need for extensive surgical excision, which can lead to significant complications and impact on quality of life. Eligible patients will receive DaRT therapy, which delivers localized radiation directly to the tumor, potentially improving outcomes and reducing recurrence rates. The study will assess the treatment's effectiveness and safety profile in this specific cancer population.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and over with newly diagnosed or recurrent squamous cell carcinoma of the vulva that is amenable to treatment with DaRT.
Not a fit: Patients with non-squamous histology or those with significant comorbidities that increase the risk of radiation toxicity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a less invasive option for vulva cancer patients, potentially improving survival rates and quality of life.
How similar studies have performed: While the use of alpha-emitters in cancer treatment is a novel approach, preliminary studies have shown promise in similar applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Cambridge, Cambridgehire
- Cambridge University Hospitals NHSFT — Cambridge, Cambridgehire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Li Tee Tan — Cambridge University Hospitals NHS Foundation Trust
- Study coordinator: Urology, Haematology and Medical Devices Team Clinical Trials Unit - Cancer Theme
- Email: cctuc@addenbrookes.nhs.uk
- Phone: 01223216083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.