Neoplasms

Mouth and Tooth Diseases

All Conditions

Salivary Gland Neoplasms

(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.

8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks

carbon ion boost

Marc W Muenter, MD

The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, and toxicity. Planned accrual of the trial includes 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/ fraction).

Local control in malignant salivary gland tumours is dose dependent. High local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/ carbon ion) therapy. Considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects.

Methods/ design:

The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, toxicity (incl. mucositis CTC °I-II and late toxicity at 3 years post RT)

CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC

Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC

to evaluate local control at 3 years post RT

evaluation of acute radiation effects (other than mucositis CTC°C) 6-8 weeks post completion of treatment

to evaluate disease-free survival at 3 years post radiotherapy

Heidelberg University

PD Dr. MW Münter

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Juergen Debus, MD PhD

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.

Local control in sinonasal malignancies is dose dependent. However, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/ design:

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and late toxicity at 2 years post RT)are secondary endpoints.

Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy

Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

patients receive induction chemotherapy with TPF for a maximum of 3 cycles followed by radioimmunotherapy with cetuximab as intensity-modulated radiotherapy (IMRT) plus carbon ion boost

TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and toxicity of the combination regimen.

TPF-C-HIT is a prospective, monocentric phase II trial efficacy, as measured by control and survival rates, as well as toxicity (acute and late effects) of the combined treatment with TPF-induction followed by radioimmunotherapy with the EGFR-antibody cetuximab and carbon ion boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN). As long-term local control remains a therapeutic challenge in advanced head and neck cancer, locoregional control was chosen as the primary endpoint. Secondary endpoints are survival rates (disease-free survival, PFS, OS), acute and late radiation effects as well as adverse events. For development of prognostic markers, proteomic and genomic analyses are also included in the secondary endpoints.

TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors

Induction Chemotherapy With TPF Followed by Radioimmunotherapy With Cetuximab and Intensity Modulated Radiotherapy (IMRT) Plus Carbon Ion Boost for Locally Advanced Tumors of the Oro-, Hypopharynx and Larynx: TPF-C-HIT

The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year

includes any adverse events attributable to the combined treatment not otherwise specified

proteomic and genomic analyses designed to investigate changes during therapy, therefore analyses are carried out at 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC	NCT01154270	Malignancy Salivary Glands Tumor	carbon ion boos...	18 Years - 80 Years	Heidelberg University
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)	NCT01220752	Sinonasal Malig... Adenocarcinoma ...	carbon ion boos...	18 Years - 80 Years	Heidelberg University
TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors	NCT01245985	Locally Advance...	carbon ion boos...	18 Years - 70 Years	Heidelberg University

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