Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO)

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 Overview

• Status: Recruiting
• Conditions: Adenoid Cystic Carcinoma
• Intervention / Treatment: Radiation: Carbon ion irradiation; Radiation: Bimodal irradiation

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Klaus Herfarth, Prof. Dr.; Phone Number: +49 6221 56 8201; Email: klaus.herfarth@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University of Heidelberg, Radiooncology, HIT
    • Contact: Klaus Herfarth, Prof. Dr.; Phone Number: +49 6221 568201; Email: klausherfarth@med.uni-heidelberg.de
    • Principal Investigator: Klaus Herfarth, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbon Ion irradiation; 22 x 3 Gy(RBE) Carbon Ions	Radiation: Carbon ion irradiation; 22 x 3 Gy(RBE) Carbon Ions
Active Comparator: Bimodal Arm; 25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost	Radiation: Bimodal irradiation; 25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from loco-regional progression	Freedom from loco-regional tumor progression according to MR imaging	at 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival	at 3 and 5 years
Overall survival	Overall survival	at 3 and 5 years
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
Late toxicities	Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)	up to 5 years

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Klaus Herfarth, Prof. Dr., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Radiation therapy; ACC; carbon ion; heavy ion; salivary gland tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Adenoid Cystic
• Other Study ID Numbers: ACCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No