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

Phase 2
18 Years
80 Years
Open (Enrolling)
Malignancy, Salivary Glands, Tumor

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Trial Information

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

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/

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)

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

mucositis ≥ CTC°3

Outcome Time Frame:

6-8 weeks post completion of treatment

Safety Issue:


Principal Investigator

Marc W Muenter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Radiation Oncology, INF 400, 69120 Heidelberg


Germany: "Bundesamt für Strahlenschutz" (German Radiation Protection Authority)

Study ID:




Start Date:

June 2010

Completion Date:

September 2013

Related Keywords:

  • Malignancy
  • Salivary Glands
  • Tumor
  • cancer of the salivary glands
  • radiation
  • carbon ion therapy
  • Neoplasms