Clinical trial · Interventional
CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC
Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC
NCT01154270CI-TRIAL-00010120COSMICunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Salivary Glands | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon ion boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT + C12-boost
- description
- (8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
- interventionNames
- Radiation: carbon ion boost
Primary outcomes (1)
- measure
- mucositis ≥ CTC°3
- timeFrame
- 6-8 weeks post completion of treatment
Secondary outcomes (4)
- measure
- local control
- timeFrame
- 3 years post RT
- description
- to evaluate local control at 3 years post RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (22)
- BACKGROUNDSpiro RH. Salivary neoplasms: overview of a 35-year experience with 2,807 patients. Head Neck Surg. 1986 Jan-Feb;8(3):177-84. doi: 10.1002/hed.2890080309. PMID 3744850
- BACKGROUNDChen AM, Granchi PJ, Garcia J, Bucci MK, Fu KK, Eisele DW. Local-regional recurrence after surgery without postoperative irradiation for carcinomas of the major salivary glands: implications for adjuvant therapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):982-7. doi: 10.1016/j.ijrobp.2006.10.043. Epub 2007 Jan 22. PMID 17241753
- BACKGROUNDGurney TA, Eisele DW, Weinberg V, Shin E, Lee N. Adenoid cystic carcinoma of the major salivary glands treated with surgery and radiation. Laryngoscope. 2005 Jul;115(7):1278-82. doi: 10.1097/01.MLG.0000165381.64157.AD. PMID 15995521
- BACKGROUNDMendenhall WM, Morris CG, Amdur RJ, Werning JW, Hinerman RW, Villaret DB. Radiotherapy alone or combined with surgery for adenoid cystic carcinoma of the head and neck. Head Neck. 2004 Feb;26(2):154-62. doi: 10.1002/hed.10380. PMID 14762884
- BACKGROUNDChen AM, Bucci MK, Weinberg V, Garcia J, Quivey JM, Schechter NR, Phillips TL, Fu KK, Eisele DW. Adenoid cystic carcinoma of the head and neck treated by surgery with or without postoperative radiation therapy: prognostic features of recurrence. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):152-9. doi: 10.1016/j.ijrobp.2006.04.014. PMID 16904520
- BACKGROUNDGarden AS, Weber RS, Ang KK, Morrison WH, Matre J, Peters LJ. Postoperative radiation therapy for malignant tumors of minor salivary glands. Outcome and patterns of failure. Cancer. 1994 May 15;73(10):2563-9. doi: 10.1002/1097-0142(19940515)73:103.0.co;2-x. PMID 8174054
- BACKGROUNDTerhaard CH, Lubsen H, Van der Tweel I, Hilgers FJ, Eijkenboom WM, Marres HA, Tjho-Heslinga RE, de Jong JM, Roodenburg JL; Dutch Head and Neck Oncology Cooperative Group. Salivary gland carcinoma: independent prognostic factors for locoregional control, distant metastases, and overall survival: results of the Dutch head and neck oncology cooperative group. Head Neck. 2004 Aug;26(8):681-92; discussion 692-3. doi: 10.1002/hed.10400.