Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Study Overview
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Brief Summary
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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.

Official Title
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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Conditions
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Adenoid Cystic Carcinoma

Intervention / Treatment
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* Radiation: Carbon ion irradiation
* Radiation: Bimodal irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon Ion irradiation<br>22 x 3 Gy(RBE) Carbon Ions | Radiation: Carbon ion irradiation<br>* 22 x 3 Gy(RBE) Carbon Ions<br>|
| Active Comparator: Bimodal Arm<br>25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost | Radiation: Bimodal irradiation<br>* 25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from loco-regional progression | Freedom from loco-regional tumor progression according to MR imaging | at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival | at 3 and 5 years | 
| Overall survival | Overall survival | at 3 and 5 years | 
| Acute toxicities | Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade) | during and up to 6 weeks after radiotherapy | 
| Late toxicities | Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade) | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon ion, heavy ion, salivary gland tumor, ACC, Radiation therapy