Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Phase 2

Recruiting

• Conditions: Adenoid Cystic Carcinoma
• Interventions: Radiation: Carbon ion irradiation; Radiation: Bimodal irradiation

• Registration Number: NCT04214366
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-24
• Study Start: 2019-12-01
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2020-01-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2027-12-01
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 314

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon Ion irradiation	Carbon ion irradiation	22 x 3 Gy(RBE) Carbon Ions
Bimodal Arm	Bimodal irradiation	25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost

Primary Outcome Measures

Name	Time	Method
Freedom from loco-regional progression	at 5 years	Freedom from loco-regional tumor progression according to MR imaging

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	at 3 and 5 years	Progression-free survival
Acute toxicities	during and up to 6 weeks after radiotherapy	Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)
Late toxicities	up to 5 years	Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)
Overall survival	at 3 and 5 years	Overall survival

Trial Locations

Locations (1)

University of Heidelberg, Radiooncology, HIT; 🇩🇪 Heidelberg, Germany