Clinical trial · Interventional
Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma
Phase I/II Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma
NCT01005043CI-TRIAL-00042682completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this trial are the determination of feasibility and toxicity of Heavy Ion Radiotherapy (C12) in patients with non-resectable osteosarcoma. Secondary endpoints are tumor response, disease free survival and overall survival. The aim is to improve outcome for patients with non-resectable osteosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| heavy ion radiotherapy (C12) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- heavy ion radiotherapy
- description
- Heavy ion radiotherapy of osteosarcoma with 60 to 66 GyE (20-22 days). Before and after radiotherapy, but not during radiotherapy, chemotherapy is recommended to standard therapy protocols like EURAMOS 1 which is not part of this study.
- interventionNames
- Radiation: heavy ion radiotherapy (C12)
Primary outcomes (1)
- measure
- feasibility, toxicity (tox) measured by the CTC Criteria .Unacceptable:grade 4 tox. A rate of acute tox (≤ 3 months during/after RT) > grade 3 of ≤ 5% and a rate of late tox > grade 3 of ≤ 3% will be acceptable.
- timeFrame
- before, weekly during RT and at follow-up (1, 6 and 19 weeks, 6, 12, 24, 36 48 and 60 months after RT).
Secondary outcomes (1)
- measure
- tumor response (RECIST criteria), disease free survival, overall survival and description of FDG-PET characteristics before and after RT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of high grade osteosarcoma with or without metastases * Non-resectable tumor of the pelvis, the skull base or the spine, respectively, incomplete or intralesional tumor resection - as confirmed after evaluation by two orthopedic surgeons (respectively neurosurgeons in case of spine tumors): one local surgeon and one referee surgeon of the University of Heidelberg. * Age older than 6 years before start of radiotherapy * Adequate performance status (Karnofsky \>60%) * Adequate blood cell production before the start of HIT in patients with pelvic or spine tumors as defined by: total white cell count (WBC) \>1,0/nl; neutrophils \> 200/µl; platelet count \>20/nl * No febrile neutropenia (neutrophils \< 200/µl) * Written informed consent of the patient or the legal guardians Non-resectable tumor site means primary tumors affecting anatomic areas of the human body where a surgical total resection (R0) of the tumor is not possible for technical reasons, for example osteosarcoma of the pelvis, spine or the skull base. In any other cases, surgical resection is recommended. Non-resectability has to be confirmed after evaluation by two orthopedic surgeons (respectively neurosurgeons in case of spine tumors): one local surgeon and one referee surgeon of the University of Heidelberg. In some cases surgery of the tumor might be possible after HIT. Then we recommend surgical resection of residual tumor afterwards. Exclusion Criteria: * Age younger than 6 years * Previous radiotherapy of the field that has to be radiated now * Implanted metal within the planned radiation field, that leads to significant artefacts within the target volume * Patients receiving any other investigational agents during the time of HIT * Performance status (Karnofsky) \< 60%) * Pregnancy * No written informed consent of patient or the legal guardians
References
Publications (5)
- BACKGROUNDBielack SS, Wulff B, Delling G, Gobel U, Kotz R, Ritter J, Winkler K. Osteosarcoma of the trunk treated by multimodal therapy: experience of the Cooperative Osteosarcoma study group (COSS). Med Pediatr Oncol. 1995 Jan;24(1):6-12. doi: 10.1002/mpo.2950240103. PMID 7968796
- BACKGROUNDKamada T, Tsujii H, Tsuji H, Yanagi T, Mizoe JE, Miyamoto T, Kato H, Yamada S, Morita S, Yoshikawa K, Kandatsu S, Tateishi A; Working Group for the Bone and Soft Tissue Sarcomas. Efficacy and safety of carbon ion radiotherapy in bone and soft tissue sarcomas. J Clin Oncol. 2002 Nov 15;20(22):4466-71. doi: 10.1200/JCO.2002.10.050. PMID 12431970
- BACKGROUNDOya N, Kokubo M, Mizowaki T, Shibamoto Y, Nagata Y, Sasai K, Nishimura Y, Tsuboyama T, Toguchida J, Nakamura T, Hiraoka M. Definitive intraoperative very high-dose radiotherapy for localized osteosarcoma in the extremities. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):87-93. doi: 10.1016/s0360-3016(01)01603-0. PMID 11516856
- BACKGROUNDZhang H, Yoshikawa K, Tamura K, Tomemori T, Sagou K, Tian M, Kandatsu S, Kamada T, Tsuji H, Suhara T, Suzuki K, Tanada S, Tsujii H. [(11)C]methionine positron emission tomography and survival in patients with bone and soft tissue sarcomas treated by carbon ion radiotherapy. Clin Cancer Res. 2004 Mar 1;10(5):1764-72. doi: 10.1158/1078-0432.ccr-0190-3. PMID 15014030
- DERIVEDBlattmann C, Oertel S, Schulz-Ertner D, Rieken S, Haufe S, Ewerbeck V, Unterberg A, Karapanagiotou-Schenkel I, Combs SE, Nikoghosyan A, Bischof M, Jakel O, Huber P, Kulozik AE, Debus J. Non-randomized therapy trial to determine the safety and efficacy of heavy ion radiotherapy in patients with non-resectable osteosarcoma. BMC Cancer. 2010 Mar 12;10:96. doi: 10.1186/1471-2407-10-96. PMID 20226028