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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

RecruitingPhase 2Ages 18 Years - 80 YearsAllHeidelberg University
NCT04214366 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Carbon ion irradiation
  • Bimodal irradiation
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Where

1 site
University of Heidelberg, Radiooncology, HIT
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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