Adenoid Cystic Carcinoma
Conditions
Keywords
carbon ion, heavy ion, salivary gland tumor, ACC, Radiation therapy
Brief summary
Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.
Interventions
RADIATIONCarbon ion irradiation
22 x 3 Gy(RBE) Carbon Ions
RADIATIONBimodal irradiation
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenoid cystic carcinoma in the head and neck area * Indication for irradiation: * non-operable or * R1/R2 resected or * perineural sheat invasion (Pn+) or * pT3/pT4 * Informed consent * KI \> 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible) * Age 18-80 years
Exclusion criteria
* rejection of the study by the patient * Patient is not able to consent * Stage IV (distant metastases), except lung metastases \< 1cm * lymph node involvement (clinical or pathological) * Previous radiotherapy in the head and neck area * Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...) * Contraindication to MR imaging * Simultaneous participation in another clinical study that could influence the outcome of this study or the other study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from loco-regional progression | at 5 years | Freedom from loco-regional tumor progression according to MR imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | at 3 and 5 years | Progression-free survival |
| Overall survival | at 3 and 5 years | Overall survival |
| Acute toxicities | during and up to 6 weeks after radiotherapy | Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade) |
| Late toxicities | up to 5 years | Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade) |
Countries
Germany
Contacts
Primary ContactKlaus Herfarth, Prof. Dr.
Outcome results
None listed