Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Head and Neck Neoplasms

Sarcopenia

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

the patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment

questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement

as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

blood biomarkers

Rossana Ingargiola, MD

Cristina Bono, MSc

The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:

* Acute toxicity: within 3 months from the beginning of particle RT
* Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy

Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated With Curative Hadrontherapy: a Prospective Monoinstitutional Study

measurement of sarcopenia to evaluate the development of the affection

CNAO National Center of Oncological Hadrontherapy

Skin and Connective Tissue Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Micronutrients

Cobalt

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.

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.

heavy ion radiotherapy (C12)

Juergen Debus, Head of Dep.

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.

Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For effective treatment, local control of the tumor is absolutely critical, because the chances of long term survival are \<10% and might effectively approach zero if a complete surgical resection of the tumor is not possible. Up to date there is no curative treatment protocol for patients with non-resectable osteosarcomas, who are excluded from current osteosarcoma trials , e.g. EURAMOS1. Local photon radiotherapy has previously been used in small series and in an uncontrolled, highly individualized fashion, which, however, documented that high dose radiotherapy can, in principle, be used to achieve local control. Generally the radiation dose that is necessary for a curative approach can hardly be achieved with conventional photon radiotherapy in patients with non-resectable tumors that are usually located near radiosensitive critical organs such as the brain, the spine or the pelvis. In these cases Heavy Ion Radiotherapy (HIT) may offer a promising new alternative. Moreover, compared with photons, heavy ion particles provide a higher physical selectivity because of their finite depth coverage in tissue. They achieve a higher relative biological effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone and soft tissue sarcomas have already shown favorable results.

Methods/Design: This is a monocenter, non-randomized study for patients older than 6 years of age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent (GyE). Weekly fractionation of 6 x 3 Gy E is used. HIT will be administered exclusively at the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of non-resectable osteosarcoma before and after HIT will be investigated prospectively. Systemic disease before and after HIT is targeted by standard chemotherapy protocols and is not part of this trial.

The primary objectives of this trial are the determination of feasibility and toxicity of HIT. Secondary endpoints are tumor response, disease free survival and overall survival. The aim is to improve outcome for patients with non-resectable osteosarcoma.

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

Dietmar Hopp Stiftung

University Hospital Heidelberg

Prof. Dr. Dr. Jürgen Debus

Carcinoma

Carcinoma, Adenoid Cystic

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Adenoid Cystic Carcinoma

Antineoplastic Agents

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).

Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).

Apatinib will be used as induction therapy in experimental arm.

Same total dose and fractionation will be used in both arms.

Particle Therapy

Lin Kong, MD

Jiyi Hu, MD

Jiade J Lu, MD

It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.

The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.

Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma

A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma	NCT01005043	Osteosarcoma	heavy ion radio...	6 Years -	University Hospital Heidelberg
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma	NCT01005043	Osteosarcoma	heavy ion radio...	6 Years -	University Hospital Heidelberg
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma	NCT02942693	Adenoid Cystic ...	Apatinib Particle Therap...	18 Years - 65 Years	Shanghai Proton and Heavy Ion Center

Spots Global Cancer Trial Database for particle therapy