Clinical trial NCT01154270: CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC
Official title: Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignancy
Salivary Glands
Tumor
Keywords: cancer of the salivary glands
radiation
carbon ion therapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: mucositis ≥ CTC°3
timeFrame: 6-8 weeks post completion of treatment
Secondary outcomes:
measure: local control
timeFrame: 3 years post RT
measure: acute toxicity
timeFrame: 6-8 weeks post completion of treatment
measure: late toxicity
timeFrame: 3 years post radiotherapy
measure: disease-free survival
timeFrame: 3 years post treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dept. of Radiation Oncology, INF 400
Study officials:
affiliation: Dept. of Radiation Oncology, INF 400, 69120 Heidelberg
name: Marc W Muenter, MD
role: PRINCIPAL_INVESTIGATOR
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