NCT03297788: ENCEPHALON

Whole Brain Radiation Therapy Alone vs. Radiosurgery for SCLC Patients With 1-10 Brain Metastases

Completed NA Last updated 5 January 2024

What this trial tests

NA trial testing SRS in SCLC in 56 participants. Completed in 1 December 2023.

Timeline

1 December 2017

Primary endpoint
1 October 2023

1 December 2023

Quick facts

Lead sponsor	Juergen Debus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 December 2017
Primary completion	1 October 2023
Estimated completion	1 December 2023
Sites	1 location across Germany

Drugs / interventions tested

• SRS — full drug profile →
• WBRT — full drug profile →

Conditions studied

• SCLC — all drugs for SCLC →
• Brain Metastases — all drugs for Brain Metastases →

Sponsor

Juergen Debus

Who can join

18 and older, any sex, with SCLC or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients suffering from small cell lung cancer (SCLC) are at high risk for developing brain metastases (BM). To prevent a clinical manifestation of preexisting microscopic brain dissemination, prophylactic cranial irradiation (PCI) is offered to both limited and extensive disease patients, if they respond to first line regime, thus being at risk or at chance to develop clinical brain metastases. However, up to 10-15% of patients present with BM at initial diagnosis. If MRI is used as a diagnostic tool for initial staging the number even increases up to 15-20%. Additionally, between 40 - 50% of patients develop BM until time of death and the risk of developing BM further increases with prolonged survival. Treatment options are usually limited to WBRT and palliative chemotherapy but the actual effect of therapeutic WBRT has mainly been studied in small retrospective and nonrandomized studies. WBRT has been established as the treatment standard in patients with cerebral metastases from SCLC, however, it has only modest efficacy. Results might be improved by additional dose escalation. A SRS to cerebral metastases may be indicated in patients with intracranial disease, and the current protocol is aimed at exploring the neurocognition and efficacy of SCLC in patients with brain metastases treated with SRS or WBRT.

The present trial aims to exploratory investigate the treatment response to ´conventional whole brain radiotherapy´ (WBRT) and ´stereotactic radiotherapy´(SRS) in SCLC patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of brain metastases in lung cancer: evolving roles for radiation and systemic treatment in the era of targeted and immune therapies.
   Myall NJ, Yu H, Soltys SG, Wakelee HA, et al · · 2021 · cited 36× · PMID 34859233 · DOI 10.1093/noajnl/vdab106
2. What is the role of radiotherapy for extensive-stage small cell lung cancer in the immunotherapy era?
   Nesbit EG, Leal TA, Kruser TJ. · · 2019 · cited 31× · PMID 31673520 · DOI 10.21037/tlcr.2019.05.01
3. A Dutch phase III randomized multicenter trial: whole brain radiotherapy versus stereotactic radiotherapy for 4-10 brain metastases.
   Hartgerink D, Bruynzeel A, Eekers D, Swinnen A, et al · · 2021 · cited 27× · PMID 33738451 · DOI 10.1093/noajnl/vdab021
4. Prophylactic cranial irradiation in small-cell lung cancer: update on patient selection, efficacy and outcomes.
   Manapov F, Käsmann L, Roengvoraphoj O, Dantes M, et al · · 2018 · cited 27× · PMID 30323698 · DOI 10.2147/lctt.s137577
5. Current Management and Progress in Radiotherapy for Small Cell Lung Cancer.
   Tjong MC, Mak DY, Shahi J, Li GJ, et al · · 2020 · cited 23× · PMID 32760673 · DOI 10.3389/fonc.2020.01146
6. Whole brain radiation therapy alone versus radiosurgery for patients with 1-10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial.
   Bernhardt D, Hommertgen A, Schmitt D, El Shafie R, et al · · 2018 · cited 22× · PMID 30012190 · DOI 10.1186/s13063-018-2745-x
7. Strategies to Preserve Cognition in Patients With Brain Metastases: A Review.
   Robin TP, Rusthoven CG. · · 2018 · cited 20× · PMID 30356657 · DOI 10.3389/fonc.2018.00415
8. A Cohort Study of Stereotactic Radiosurgery Results for Patients With 5 to 15 Versus 2 to 4 Brain Metastatic Tumors.
   Yamamoto M, Sato Y, Higuchi Y, Kasuya H, et al · · 2020 · cited 18× · PMID 32529129 · DOI 10.1016/j.adro.2019.11.001