NCT04214366: ACCO

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Recruiting now Phase 2 Last updated 30 November 2023

What this trial tests

Phase 2 trial testing Carbon ion irradiation in Adenoid Cystic Carcinoma in 314 participants. Currently enrolling.

Timeline

1 December 2019

Primary endpoint
1 December 2027

1 December 2032

Quick facts

Lead sponsor	Heidelberg University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	314
Start date	1 December 2019
Primary completion	1 December 2027
Estimated completion	1 December 2032
Sites	1 location across Germany

Drugs / interventions tested

• Carbon ion irradiation
• Bimodal irradiation

Conditions studied

• Adenoid Cystic Carcinoma — all drugs for Adenoid Cystic Carcinoma →

Sponsor

Heidelberg University

Who can join

Adults 18 to 80, any sex, with Adenoid Cystic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Particle therapy in the future of precision therapy.
   Schaub L, Harrabi SB, Debus J. · · 2020 · cited 34× · PMID 32795176 · DOI 10.1259/bjr.20200183
2. Biological Rationale and Clinical Evidence of Carbon Ion Radiation Therapy for Adenoid Cystic Carcinoma: A Narrative Review.
   Loap P, Vischioni B, Bonora M, Ingargiola R, et al · · 2021 · cited 18× · PMID 34917512 · DOI 10.3389/fonc.2021.789079
3. The Role of Particle Therapy in Adenoid Cystic Carcinoma and Mucosal Melanoma of the Head and Neck.
   Ebner DK, Malouff TD, Frank SJ, Koto M. · · 2021 · cited 15× · PMID 34285953 · DOI 10.14338/ijpt-d-20-00076
4. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study.
   Lang K, Adeberg S, Harrabi S, Held T, et al · · 2021 · cited 12× · PMID 34266402 · DOI 10.1186/s12885-021-08473-5
5. A future directions of renal cell carcinoma treatment: combination of immune checkpoint inhibition and carbon ion radiotherapy.
   Zheng Z, Yang T, Li Y, Qu P, et al · · 2024 · cited 9× · PMID 39091498 · DOI 10.3389/fimmu.2024.1428584
6. Assessing the Impact of Charged Particle Radiation Therapy for Head and Neck Adenoid Cystic Carcinoma: A Systematic Review and Meta-Analysis.
   Tan M, Chen Y, Du T, Wang Q, et al · · 2024 · cited 4× · PMID 38773763 · DOI 10.1177/15330338241246653