Actively Recruiting
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Led by Heidelberg University · Updated on 2023-11-30
314
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenoid cystic carcinoma in the head and neck area
- Indication for irradiation: non-operable or R1/R2 resected or perineural sheath invasion (Pn+) or tumor stage pT3/pT4
- Provided informed consent
- Karnofsky Index above 60% or ECOG performance status 0 or 1 (self-sufficient, normal activity or unable to work)
- Age between 18 and 80 years
You will not qualify if you...
- Patient refuses to participate in the study
- Unable to provide informed consent
- Stage IV disease with distant metastases, except lung metastases smaller than 1 cm
- Lymph node involvement clinically or pathologically
- Previous radiotherapy in the head and neck area
- Active medical implants without radiation authorization (e.g., cardiac pacemaker, defibrillator)
- Contraindication to MRI
- Simultaneous participation in another clinical study that could affect outcomes
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Heidelberg, Radiooncology, HIT
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
K
Klaus Herfarth, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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