Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Adenoid Cystic Carcinoma Clinical Trial

— ACCO  

Official title:

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04214366
• Other study ID #: ACCO
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2019
• Est. completion date: December 1, 2032

Study information

• Verified date: November 2023
• Source: Heidelberg University
• Contact: Klaus Herfarth, Prof. Dr.
• Phone: +49 6221 56 8201
• Email: klaus.herfarth[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: December 1, 2032
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic

Intervention

Radiation:
• Carbon ion irradiation
22 x 3 Gy(RBE) Carbon Ions
• Bimodal irradiation
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Locations

Country	Name	City	State
Germany	University of Heidelberg, Radiooncology, HIT	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from loco-regional progression	Freedom from loco-regional tumor progression according to MR imaging	at 5 years
Secondary	Progression-free survival	Progression-free survival	at 3 and 5 years
Secondary	Overall survival	Overall survival	at 3 and 5 years
Secondary	Acute toxicities	Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)	during and up to 6 weeks after radiotherapy
Secondary	Late toxicities	Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)	up to 5 years