Carbon ion irradiation for adenoid cystic carcinoma
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
This study is testing if carbon ion therapy can be a more effective and quicker treatment for people with adenoid cystic carcinoma, a rare type of head and neck tumor.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04214366 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of carbon ion irradiation as a sole treatment for adenoid cystic carcinoma, a rare head and neck tumor. Conducted at Heidelberg University Hospital, it aims to provide a shorter treatment duration of about four weeks with 22 fractions of carbon ion therapy. The primary goal is to improve local tumor control rates from 60% to 70% after five years. Patients will be monitored for five years following treatment to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with histologically confirmed adenoid cystic carcinoma who require irradiation and meet specific health criteria.
Not a fit: Patients with stage IV disease, significant lymph node involvement, or those who have previously undergone radiotherapy in the head and neck area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance local control of adenoid cystic carcinoma and potentially improve patient outcomes.
How similar studies have performed: While carbon ion therapy has shown promise in other contexts, this specific approach for adenoid cystic carcinoma is novel and has not been extensively tested in Europe.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg
- University of Heidelberg, Radiooncology, HIT — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: Klaus Herfarth, Prof. Dr. — University Hospital Heidelberg
- Study coordinator: Klaus Herfarth, Prof. Dr.
- Email: klaus.herfarth@med.uni-heidelberg.de
- Phone: +49 6221 56 8201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.