Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
| National Center for Radiation Research in Oncology Dresden/Heidelberg | OTHER |
Not provided
Not provided
Not provided
This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with different radiation modalities - protons or photons. Patients with different kinds of brain tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment.
Non-randomised 2-arm phase II trial on comparison of proton versus photon radiotherapy in brain tumours using standard doses and standard combined chemotherapy protocols. Patients are assigned to the treatment groups by their own choice or availability of the treatment. Patients are stratified into 4 groups, (1) supratentorial grad III/ IV tumours without pre-irradiation; (2) supratentorial grade I/II tumours without pre-irradiation; (3) infratentorial tumours without pre-irradiation; (4) patients with pre-irradiation >40 Gy in the tumour area. Radiotherapy doses of 54-60 Gy(RBE) are applied in group 1-3 using normal fractionated schedules. In group 4, 30 Gy(RBE)/ 5 Gy(RBE) per fraction or 36 Gy(RBE) with 2 Gy(RBE) per fraction are allowed. Primary endpoint is chronic toxicity and quality of life. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment. Events for chronic toxicity are toxicities observed later than 3 months after end of radiotherapy and scored CTC-AE4.0 >grade 2 or a decrease in Quality of life by >10% (EORTC-QLQ C30 and BN20) or a decrease in neuropsychological functioning by >10% (MoCa test). All statistical calculations apply to group (1), i.e. supratentorial grade II/IV tumours without pre-irradiation, all other arms are closed when group (1) is closed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supratentorial, grade III/IV, photon | Active Comparator | Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients. |
|
| supratentorial, grade III/IV, proton | Experimental | Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients. |
|
| supratentorial, grade I/II, photon | Active Comparator | Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors. |
|
| supratentorial, grade I/II, proton | Experimental | Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors. |
|
| infratentorial, photon | Active Comparator | Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients. |
|
| infratentorial, proton |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation with protons | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| late toxicity as cumulative measure | Events for the endpoint are:
| 1 year (or at least 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumour control | Local tumour control as Regression or stable disease measured in follow-up MRI | 1 year and 2 years |
| Overall survival | Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mechthild Krause, Prof. | Contact | +49 351 458 5441 | mechthild.krause@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Mechthild Krause, Prof. | University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology | Recruiting | Dresden | 01307 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011827 | Radiation |
| D011522 | Protons |
| D017785 | Photons |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients. |
|
| pre-radiation, photon | Active Comparator | > 40Gy in the region of recurrence. Radiation with photons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE). |
|
| pre-radiation, proton | Experimental | > 40Gy in the region of recurrence. Radiation with protons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE). |
|
| Radiation with photons | Radiation |
|
| 1 year and 2 years |
| Acute toxicity | Acute toxicity according to CTCAE4.0 score >/= grade II | 3 months after treatment |
| late toxicity as cumulative measure | Events for the endpoint are:
| 2 years |
| University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology | Recruiting | Marburg | 35043 | Germany |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004573 |
| Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |