Clinical Trials Logo

Clinical Trial Summary

The study is a prospective randomised clinical phase III trial. Proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.


Clinical Trial Description

The study is a prospective randomised clinical phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial.

Proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.

Patients with skull base chondrosarcomas will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume definition will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment will be 60 Gy E ± 5% and 70 Gy E ± 5% (standard dose) in proton therapy respectively. The 5 year local-progression free survival (LPFS) rate will be analysed as primary end point. Overall survival, progression free and metastasis free survival, patterns of recurrence, local control rate and morbidity are the secondary end points. Plan quality is also a matter of interest. ;


Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01182753
Study type Interventional
Source Heidelberg University
Contact Anna V. Nikoghosyan, MD
Phone +496221568202
Email anna.nikoghosyan@med.uni-heidelberg.de
Status Recruiting
Phase Phase 3
Start date August 2010
Completion date August 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05039801 - IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors Phase 1
Recruiting NCT04553692 - Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers Phase 1
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Recruiting NCT04040205 - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Phase 2
Not yet recruiting NCT06029478 - Understanding Engagement Trends in Chondrosarcoma Clinical Trials
Completed NCT01553539 - Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery Phase 2
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Active, not recruiting NCT04521686 - Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations Phase 1
Recruiting NCT03715933 - Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas Phase 1
Completed NCT02496741 - Metformin And Chloroquine in IDH1/2-mutated Solid Tumors Phase 1/Phase 2
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Terminated NCT00543712 - A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g) Phase 2
Recruiting NCT05861245 - Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base N/A
Completed NCT00464620 - Trial of Dasatinib in Advanced Sarcomas Phase 2
Recruiting NCT04278781 - AG-120 in People With IDH1 Mutant Chondrosarcoma Phase 2
Recruiting NCT04055220 - Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas N/A
Recruiting NCT04673942 - A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors Phase 2
Completed NCT01560260 - Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors Phase 2
Completed NCT01609179 - IPI-926 Extension Protocol for Continuation of Treatment With IPI-926 N/A
Recruiting NCT06387485 - A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning N/A