Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO)

Heidelberg University

Status and phase

Enrolling

Phase 2

Conditions

Adenoid Cystic Carcinoma

Treatments

Radiation: Carbon ion irradiation

Radiation: Bimodal irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT04214366

ACCO

Details and patient eligibility

About

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.

Enrollment

314 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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