CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 314 target
Drug / intervention
Carbon ion irradiation +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed adenoid cystic carcinoma in the head and neck area
  • ✓Non-operable, R1/R2 resected, perineural sheath invasion (Pn+), or pT3/pT4 stage
  • ✓Age 18-80 years
  • ✓ECOG 0/1 or KI >60%
Key exclusion· 8
  • ✕Stage IV with distant metastases (except lung metastases <1cm)
  • ✕Lymph node involvement (clinical or pathological)
  • ✕Previous radiotherapy in the head and neck area
  • ✕Active medical implants without ion radiation authorization (cardiac pacemaker, defibrillator, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04214366
NCT04214366Phase 2RecruitingOn TrackUpdated 31mo ago
Long Recruiting
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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Heidelberg University·interventional·Posted Jan 2, 2020·Updated Nov 30, 2023

In Brief

A Phase 2 clinical trial evaluating Carbon ion irradiation and Bimodal irradiation for Adenoid Cystic Carcinoma. Currently recruiting, targeting 314 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenoid Cystic Carcinoma
CountriesGermany
Collaborators--

Timeline

Phase 2Recruiting
20202021202220232024202520262027202820292030203120322033
First PostedJan 2, 2020
Enrollment StartDec 1, 2019
Primary CompletionDec 1, 2027
Study CompletionDec 1, 2032
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 6.5 years agoPrimary completion in 1.4 years

Interventions

Carbon ion irradiationradiation

22 x 3 Gy(RBE) Carbon Ions

Bimodal irradiationradiation

25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost