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

Launched by CCTU- CANCER THEME · Feb 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for vulva cancer, specifically focusing on a method called diffusing alpha radiation emitters (DaRT). This treatment aims to target and shrink tumors in women with newly diagnosed or recurrent squamous cell carcinoma of the vulva. The researchers want to find out if this therapy is safe and effective, and they are currently looking for female participants aged 18 and older who have a measurable tumor that is 7 centimeters or smaller.

To be eligible for the trial, participants should have a confirmed diagnosis of vulva cancer and be in fairly good health, meaning their performance status is rated between 0 to 2 (where 0 indicates fully active and 2 indicates limited activity). Participants will need to provide written consent to join the study and should not have any serious health issues that could increase the risks associated with radiation. Throughout the trial, participants can expect to receive the DaRT treatment and be monitored for their response to it. This study could provide new hope for women battling this type of cancer.

Gender

FEMALE

Eligibility 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