CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC (COSMIC)
|ClinicalTrials.gov Identifier: NCT01154270|
Recruitment Status : Unknown
Verified April 2013 by Heidelberg University.
Recruitment status was: Active, not recruiting
First Posted : June 30, 2010
Last Update Posted : April 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malignancy Salivary Glands Tumor||Radiation: carbon ion boost||Phase 2|
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.
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).
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2013|
Experimental: IMRT + C12-boost
(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
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
- mucositis ≥ CTC°3 [ Time Frame: 6-8 weeks post completion of treatment ]
- local control [ Time Frame: 3 years post RT ]to evaluate local control at 3 years post RT
- acute toxicity [ Time Frame: 6-8 weeks post completion of treatment ]evaluation of acute radiation effects (other than mucositis CTC°C) 6-8 weeks post completion of treatment
- late toxicity [ Time Frame: 3 years post radiotherapy ]to evaluate radiation late effects
- disease-free survival [ Time Frame: 3 years post treatment ]to evaluate disease-free survival at 3 years post radiotherapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154270
|Dept. of Radiation Oncology, INF 400|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Marc W Muenter, MD||Dept. of Radiation Oncology, INF 400, 69120 Heidelberg|