Clinical trial NCT04214366: Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Official title: Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Adenoid Cystic Carcinoma
Keywords: carbon ion
heavy ion
salivary gland tumor
ACC
Radiation therapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from loco-regional progression
timeFrame: at 5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: at 3 and 5 years
measure: Overall survival
timeFrame: at 3 and 5 years
measure: Acute toxicities
timeFrame: during and up to 6 weeks after radiotherapy
measure: Late toxicities
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Radiooncology, HIT
Study officials:
affiliation: University Hospital Heidelberg
name: Klaus Herfarth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5.