large tumor volume > 150 ml
Conditions
Interventions
Group 1: Prospective registry study (pragmatic study): systematic recording and characterization of clinical outcomes in patients with large tumors receiving either conventional or spatially fractiona
Sponsors
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patient age = 18 years • ECOG score 0-2 (Karnofsky Performance Score > 70%); ECOG score 3 based solely on symptoms with expected improvement with radiation therapy (especially with analgesic radiation) • Histologically confirmed malignant tumor disease • Indication for radiation therapy of a large tumor manifestation with > 150 ml volume (gross tumor volume, GTV) • Patient capacity to consent • Patient consent (informed consent, IC)
Exclusion criteria
Exclusion criteria: • Patient refusal to participate in the study • Patient unable to consent • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study aim is to descriptively characterize the clinical outcomes and the feasibility of spatially fractionated RT of large tumors. These should also be explicitly compared with the results of established (“classic”) RT techniques. The primary endpoint is toxicity (according to CTCAE version 5.0). A first descriptive evaluation of the clinical outcomes should take place after approx. 18 months (a total of approx. 60 patients, of which 15 - 20 patients are expected to have spatially fractionated RT). Further analyzes are expected to be carried out after approx. 36 months (approx. 120 patients). | — |
Secondary
| Measure | Time frame |
|---|---|
| Important secondary endpoints include imaging changes in tumor volumes, local and distant tumor control, progression-free and overall survival, and patient-reported outcomes (in the form of quality of life questionnaires). On the other hand, this registry study is intended to advance the technical development and dosimetry of spatially fractionated radiation approaches. Therefore, the treatment plans and radiation parameters as well as the imaging and quality assurance data collected are recorded pseudonymously in order to use them for further technical analyzes and the planning of follow-up projects. These analyzes include, among others, the following endpoints: • Description of dosimetry and geometry of the RT schemes used • Testing automatic contouring and image registration tools as well as algorithms for automatically generating geometries for spatially fractionated RT • Various dose accumulation methods are calculated and evaluated • Correlation of dosimetric parameters with clinical outcomes to establish determinants of therapeutic response • In particular, modeling of the tumor response or the radiation dose necessary for tumor control based on clinical and imaging parameters • Exploration of novel “dose-painting” approaches (e.g. placement of the vertices of a lattice RT) by correlating the treatment plans with imaging data | — |
Countries
Germany
Contacts
Public ContactSebastian Regnery
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Outcome results
None listed