Adenoid cystic Carcinoma and Carbon Ion Only irradiation

Adenoid cystic Carcinoma and Carbon Ion Only irradiation - ACCO

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016792

Enrollment

314

Registered

2019-02-20

Start date

2019-12-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C07 C08 C14

Interventions

Group 1: bimodal radiotherapy (photon IMRT and C12 ion boost) Group 2: carbon ion only irradiation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Histologically confirmed adenoid cystic carcinoma in the head and neck area Indication for irradiation: - non-operable and/or - R1/R2 resected and/or - perineural sheat invasion (Pn+) and/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

Exclusion criteria: Rejection of the study by the patient Patient is not able to consent Stage IV (distant metastases) lymph node involvement (clinical or pathological), with exception of pulmonary metastases of = 1 cm 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

Design outcomes

Primary

Measure	Time frame
Locoregional tumor control according to MRI imaging after 5 years	—

Secondary

Measure	Time frame
• Progression-free survival after 3 and 5 years • Overall survival after 3 and 5 years • Acute toxicities according to NCI CTC AE (Version 4.0) during and up to 6 weeks after radiotherapy (rate of toxicity > 2 grade) • Late toxicities according to NCI CTC AE (Version 4.0) from 6 weeks after radiotherapy (rate of toxicity > 2 grade) • Quality of life assessment according to EORTC QLQ-C30 and QLC H&N35	—

Measure

Time frame

• Progression-free survival after 3 and 5 years • Overall survival after 3 and 5 years • Acute toxicities according to NCI CTC AE (Version 4.0) during and up to 6 weeks after radiotherapy (rate of toxicity > 2 grade) • Late toxicities according to NCI CTC AE (Version 4.0) from 6 weeks after radiotherapy (rate of toxicity > 2 grade) • Quality of life assessment according to EORTC QLQ-C30 and QLC H&N35

—

Countries

Germany

Contacts

Public ContactStudienzentrale Heidelberg

Universitätsklinikum HeidelbergAbteilung für RadioOnkologie und Strahlentherapie

studien.radonk@med.uni-heidelberg.de06221 56 38613

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026