Overview

This trial is active, not recruiting.

Conditions malignancy, salivary glands, tumor
Treatment carbon ion boost
Phase phase 2
Sponsor Heidelberg University
Start date June 2010
End date September 2011
Trial size 54 participants
Trial identifier NCT01154270, COSMIC

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
carbon ion boost
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

Primary Outcomes

Measure
mucositis ≥ CTC°3
time frame: 6-8 weeks post completion of treatment

Secondary Outcomes

Measure
local control
time frame: 3 years post RT
acute toxicity
time frame: 6-8 weeks post completion of treatment
late toxicity
time frame: 3 years post radiotherapy
disease-free survival
time frame: 3 years post treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC
Principal investigator Marc W Muenter, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Heidelberg University.