Radiotherapy of adrenal metastases in oligometastatic cancer – A
retrospective multicenter outcome analysis


Sponsor-Investigator:

PD Dr. Judit Boda-Heggemann
Department of Radiation Oncology, Medical Faculty Mannheim
judit.boda-heggemann@umm.de

Dr. Daniel Bürgy
Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical
Faculty Mannheim, Heidelberg University, Mannheim, Germany
daniel.buergy@medma.uni-heidelberg.de

Study objective:

To analyze the toxicity and efficacy of targeted radiotherapy to adrenal metastases

Project plan:

We are planning to establish a database of patients treated with highly conformal, dose-escalated image-guided radiotherapy techniques. Such a pooled analysis would allow for the collection of roughly at least ~150 patient records or more. Patient data will be stratified according to histology and radiotherapy technique and a detailed outcome analysis will be performed. This includes the analysis of the following points:

  1. Treatment records of patients with a maximum number of 5 malignant lesions who received image-guided radiotherapy of at least one adrenal metastasis may be retrospectively included in the study
  2. Patients must have received a Biologically Effective Dose (BED) of at least 50 Gy (α/β= 10; minimum EQD-2 ≥ 41.7 Gy) with highly conformal, image-guided radiotherapy techniques
  3. Any fractionation is acceptable, as long as the BED is 50 Gy or more (EQD-2 ≥ 41.7 Gy)
  4. Patients will be stratified according to primary tumor and BED
  5. Acute toxicity of patients as defined as toxicity occurring up to 90 days post-treatment will be analyzed
  6. Late toxicity occurring after 90 days post-treatment will be analyzed
  7. Local control of the irradiated lesions will be analyzed
  8. Progression-free survival as defined as the time interval from radiotherapy to tumor progression (RECIST 1.1) or death due to any cause will be analyzed
  9. Overall survival as defined as time interval from radiotherapy to death due to any cause after radiotherapy will be analyzed
  10. Tumor-specific survival as defined as time interval from radiotherapy to tumor-specific death (all aforementioned events censored) will be analyzed

Explain added value and impact due to project

Treatment techniques for adrenal metastases vary between centres. No optimal treatment technique has been established for a specific tumor entity. Single centre series are typically too small to draw any conclusions for subgroups. Therefore, we think a pooled analysis might lead to further insights on optimal dose-/fractionation techniques for adrenal metastases. Such a publication might increase the acceptance of radiotherapy for adrenal metastases as a treatment technique for oligometastatic patients with different primary tumors within AG Stereotaxie.

Explain involvement strategy of AG Stereotaxiemember

The members would need to submit data :

- Patient data:

  • Baseline information (Tumor type, other metastatic sites, previous
  • treatments, concurrent systemic treatments)
  • Outcome data, i.e. acute toxicity, late toxicity, local control,
    progression-free survival, overall survival
  • Dose-/volume information for organs at risk and for the GTV and
    the PTV.

Quantify effort for participating AG members

The effort depends if there is already an analysis for adrenal metastases in place at the department. If an analysis has already been conducted, the effort is expected to be around 10-15 minutes per case. If there is no database in place, the effort per patient is expected to be 60 minutes, depending on the availability of electronic patient records to identify respective cases of adrenal radiotherapies.

PI support in kind / cash

  • No cash will be provided for the participants, our apology
  • PI will provide ethical approval (for the whole project), data management, analysis with according necessary personal (radiologists, radiation oncologist, physicists, students, etc.) based on the project plan, publication drafts and handling and meeting presentations
  • All participating center are very welcome to participate in the analysis, review the results in detail and access the central database at the PIs center upon request and available schedules

External financial support required?

Depending on the number of participating centers and anticipated cases (pre-screening) we may submit for external financial support for the project, however, at this stage it is not planned.

Publication strategy:

As based on the AG guidelines. For each project plan sub-analysis a publication may arise.

Authorship:

All clinics providing data can name one co-author on each publication due to the complexity of the project; clinics providing ten or more patients can name two co-authors on each publication.