Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma

NCT01005043 | Completed Phase 1

• 1 other identifier: HITHD-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Osteosarcoma

Keywords

non-resectable osteosarcoma; heavy ion radiotherapy; particle therapy; safety; toxicity; survival; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

heavy ion radiotherapy

EXPERIMENTAL

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.

Radiation: heavy ion radiotherapy (C12)

Interventions

heavy ion radiotherapy (C12) RADIATION

Desired target of Heavy ion radiotherapy is 60 to 66 Cobalt Gray Equivalent (GyE), whenever possible. It is applied through 1 - 3 isocenter treatment portals. Dose distributions are calculated and dose volume histograms (DVH) are generated. A α/β-ratio of 2 is used for biological plan optimization. Fractionation is planned to be equivalent to 6 x 3 GyE / week. Dosage to organs at risk is minimized. Treatment continues for 20 to 22 days or until one of the following criteria applies: Other illness that prevents further administration of treatment, Patient or legal guardian decides to withdraw from the study, or changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Also known as: Particle therapy, Radiotherapy with C12, Ion therapy

heavy ion radiotherapy

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Dietmar Hopp Stiftung: collaborator

Study Sites (1)

Heidelberger Ionenstrahltherapiezentrum (HIT), Im Neuenheimer Feld 400

Heidelberg, 69120, Germany

Location

Related Publications (5)

• Bielack 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 BACKGROUND

• 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. doi: 10.1200/JCO.2002.10.050.

  PMID: 12431970 BACKGROUND

• Oya 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 BACKGROUND

• Zhang 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 BACKGROUND

• Blattmann 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 DERIVED

MeSH Terms

Conditions

Osteosarcoma

Interventions

Heavy Ion Radiotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Juergen Debus, Head of Dep.

  Heidelberger Ionenstrahltherapiezentrum, HIT, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Jürgen Debus

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 30, 2009
• Study Start: December 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

DE (1)