Abscopal effects in metastasized cancer patients treated with radiotherapy and immune checkpoint inhibitio
Recruiting
- Conditions
- Abscopal effects under radio-immunotherapy of all tumour entities treated with it
- Registration Number
- DRKS00032390
- Lead Sponsor
- niversitätsklinikum Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Patients with documented evidence of metastatic solid tumor of any entity and simultaneous RT-ICI between 06/2015 (start ICI) and 06/2021 (end RT) at participating centers.
- At least one lesion outside the irradiation field: non-irradiated lesion (outside the 10% isodose, NIL)
- Radiological images of the NILs prior to initiation of RT (at least two) and after the end of RT (at least one) to exclude an effect induced by ICI only
Exclusion Criteria
- Start of another systemic therapy during the time period being analyzed
- Inadequate imaging to assess abscopal effect or exclude response induced by ICI only
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of abscopal effects based on radiological images of non-irradiated<br>lesions: long axis diameter (nodal lesions: short axis diameter) (mm) measurement in =3 radiological images according to iRECIST:<br>- AR = Abscopal Response: Reduction by =30%<br>- AP = Abscopal Progression: Increase by =20%<br>- AC = Abscopal Control
- Secondary Outcome Measures
Name Time Method Secondary Endpoints:<br>- Survival outcomes (OS, PFS)<br>- RT-ICI concepts used (dose, fractionation, technique, sequence)<br>- Number of applied RT-courses (lifetime” RT dose)<br>- Change in laboratory parameters if available (inflammation status, nutrition status, LDH, HPV, EBV, PDL1)