Osteosarcoma Clinical Trial
Official title:
Phase I/II Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma
Verified date | January 2020 |
Source | University Hospital Heidelberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | October 2019 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Heidelberger Ionenstrahltherapiezentrum (HIT), Im Neuenheimer Feld 400 | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg | Dietmar Hopp Stiftung |
Germany,
Bielack SS, Wulff B, Delling G, Göbel 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. — View Citation
Kamada 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | before, weekly during RT and at follow-up (1, 6 and 19 weeks, 6, 12, 24, 36 48 and 60 months after RT). | ||
Secondary | tumor response (RECIST criteria), disease free survival, overall survival and description of FDG-PET characteristics before and after RT. | 6, 12, 24, 36 48 and 60 months after RT |
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