Glioma Clinical Trial
Official title:
Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial
Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy,
or radiation therapy. In most cases, a full course of radiotherapy has been applied after
primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With
modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a
second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and
8 months for recurrent WHO grade II, III and IV tumors.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile
and the high local dose deposition within the Bragg peak precise dose application and sparing
of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an
increase relative biological effectiveness (RBE), which can be calculated between 2 and 5
depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons,
however, offer an RBE which is comparable to photons.
First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of
primary high-grade gliomas showed promising results in a small and heterogeneous patient
collective.
In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared
to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in
patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose
(RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the
subsequent randomized Phase II part, the RD will be evaluated in the experimental arm,
compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.
Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II
is survival after re-irradiation at 12 months, secondary endpoint is progression-free
survival.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04539574 -
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
|
N/A | |
| Enrolling by invitation |
NCT04461002 -
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
|
||
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT03242824 -
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
|
Phase 2 | |
| Recruiting |
NCT04186832 -
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
|
N/A | |
| Completed |
NCT00424554 -
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
|
Phase 2 | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
| Completed |
NCT02805179 -
A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
|
Phase 2 | |
| Terminated |
NCT04556929 -
Enhanced Detection in Glioma Excision
|
N/A | |
| Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
| Recruiting |
NCT06043232 -
MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
|
||
| Not yet recruiting |
NCT06043765 -
Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
|
N/A | |
| Not yet recruiting |
NCT05025969 -
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
|
||
| Completed |
NCT02978261 -
Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas
|
Phase 1 | |
| Terminated |
NCT01502605 -
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
|
Phase 1 | |
| Completed |
NCT01836536 -
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
|
N/A | |
| Completed |
NCT01479686 -
iMRI Guided Resection in Cerebral Glioma Surgery
|
Phase 3 | |
| Completed |
NCT01212731 -
Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
|
||
| Not yet recruiting |
NCT00977327 -
Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors
|
N/A |