Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Who is this study for? Adult patients with Adenoid Cystic Carcinoma
What treatments are being studied? Carbon Ion Irradiation
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University of Heidelberg, Radiooncology, HIT
RECRUITING
Heidelberg
Contact Information
Primary
Klaus Herfarth, Prof. Dr.
klaus.herfarth@med.uni-heidelberg.de
+49 6221 56 8201
Time Frame
Start Date: 2019-12-01
Estimated Completion Date: 2032-12-01
Participants
Target number of participants: 314
Treatments
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Heidelberg University

This content was sourced from clinicaltrials.gov