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

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

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

Conditions
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Malignancy, Salivary Glands, Tumor

Intervention / Treatment
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* Radiation: carbon ion boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed or surgically removed malignant tumour of the salivary glands (head and neck) Inoperable tumour G2/3 Macroscopic or microscopic residual tumour (R2/ R1) or ≥T3/T4 or perineural invasion (Pn+) written informed consent pts aged 18 - 80 years effective contraception for pts in childbearing age (<12 months post beginning of menopause) Exclusion Criteria: Prior radio- or chemotherapy for tumours of the head and neck Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators Legal incapacity or limited legal capacity Positive serum/ urine beta-HCG/ pregnancy Drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT + C12-boost<br>(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE. | Radiation: carbon ion boost<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mucositis ≥ CTC°3 |  | 6-8 weeks post completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | to evaluate local control at 3 years post RT | 3 years post RT | 
| acute toxicity | evaluation of acute radiation effects (other than mucositis CTC°C) 6-8 weeks post completion of treatment | 6-8 weeks post completion of treatment | 
| late toxicity | to evaluate radiation late effects | 3 years post radiotherapy | 
| disease-free survival | to evaluate disease-free survival at 3 years post radiotherapy | 3 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer of the salivary glands, radiation, carbon ion therapy