Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

  • STATUS
    Recruiting
  • End date
    Jan 1, 2032
  • participants needed
    314
  • sponsor
    Heidelberg University
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Updated on 16 February 2024
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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.

Details
Condition Adenocarcinoma, Adenocarcinoma, Adenoid Cystic Carcinoma
Age 18years - 80years
Treatment Carbon ion irradiation, Bimodal irradiation
Clinical Study IdentifierNCT04214366
SponsorHeidelberg University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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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