Status:
UNKNOWN
CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC
Lead Sponsor:
Heidelberg University
Conditions:
Malignancy
Salivary Glands
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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....
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 (n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01154270
Start Date
June 1 2010
End Date
September 1 2013
Last Update
April 24 2013
Active Locations (1)
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1
Dept. of Radiation Oncology, INF 400
Heidelberg, Germany, 69120