ACCO: Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Sponsor

Heidelberg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04214366

Collaborator

(none)

314

Enrollment

Location

Arms

144.6

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenoid Cystic Carcinoma	Radiation: Carbon ion irradiation Radiation: Bimodal irradiation	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

314 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Actual Study Start Date :

Dec 15, 2019

Anticipated Primary Completion Date :

Jan 1, 2032

Anticipated Study Completion Date :

Jan 1, 2032

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Freedom from loco-regional progression [at 5 years]
Freedom from loco-regional tumor progression according to MR imaging

Secondary Outcome Measures

Progression-free survival [at 3 and 5 years]
Progression-free survival
Overall survival [at 3 and 5 years]
Overall 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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