Solid tumours Cancer
Conditions
Interventions
This is a non-randomised pivotal study where all patients will be treated with the DaRT device. Patients will be allocated to one of three arms:
Arm 1: Patients with curable disease (new or recurrent,
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: The participant must meet all the criteria to be included in the study: 1. Any biopsy-confirmed malignancy, new or recurrent, with or without metastatic disease 2. For patients with a known primary, repeat biopsy of recurrent/metastatic disease is desirable but not mandatory 3. Deemed likely to benefit from DaRT by treating tumour-specific multi-disciplinary team (MDT) 4. Measurable target according to RECIST v1.1 5. Target is technically amenable for coverage by DaRT sources 6. Patients with multiple target lesions are eligible if they meet all the inclusion criteria 7. Baseline imaging has been performed within 40 days of patient informed consent 8. Baseline imaging MUST also be within 60 days of DaRT insertion. 9. Last cycle of systemic treatment (chemotherapy or targeted therapy) will be given >30 days before DaRT insertion 10. For Arm 1 patients, no prior RT to the target lesion 11. For Arm 2 and Arm 3 patients, the last day of prior RT to the target lesion is >30 days before DaRT insertion 12. Age 18 years and over 13. ECOG performance status 0-2 14. Willing and able to give written informed consent to participate
Exclusion criteria
Exclusion criteria: The presence of any of the following will preclude participant inclusion: 1. Involvement in other studies that may affect evaluation of response or toxicity of DaRT in the past 30 days 2. Significant comorbidity which may influence the response to or toxicity of DaRT treatment 3. Other concomitant malignancies requiring active treatment for progressive disease 4. Pregnancy or breastfeeding 5. Unwilling to use adequate contraception for the duration of the study if they or their partner(s) are of childbearing potential 6. Contraindications to DaRT implant (e.g. abnormal clotting in patients with target lesions at sites which have a significant risk from bleeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate measured using tumour measurement and cross-sectional imaging at 6 weeks after device implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Response tate measured using tumour measurement and cross-sectional imaging at 3 months after after device implantation;Local control rate measured using tumour measurement and cross-sectional imaging at 3 months and 6 months after after device implantation | — |
Countries
England, United Kingdom
Contacts
Public ContactGiovanni Di Stefano
Outcome results
None listed