Carbon ion irradiation for adenoid cystic carcinoma
Official title: Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Run by Heidelberg University · NCT04214366 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 314 (estimated) |
| Sponsor | Heidelberg University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg) |
| Status | Recruiting |
| Started | December 1, 2019 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2032 |
| Registry record updated | November 30, 2023 |
| Trial ID | NCT04214366 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-80 with histologically confirmed adenoid cystic carcinoma who require irradiation and meet specific health criteria.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Docetaxel and SX-682 in head and neck cancers and prostate cancer
This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.
-
Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma
This study tests how well patients with T4 sinonasal adenoid cystic carcinoma tolerate the standard treatment of surgery followed by postoperative radiotherapy and what their 3-year progression-free survival looks like.
-
Neoadjuvant therapy with anlotinib and epirubicin for T4 sinonasal adenoid cystic carcinoma
This trial tests whether giving a targeted drug (anlotinib) plus chemotherapy (epirubicin) before surgery helps patients with advanced sinonasal adenoid cystic carcinoma see better outcomes.
-
Surgery Alone or with Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma
This study tests whether watching closely after surgery is as safe as adding postoperative radiotherapy for adults with completely removed (R0) early-stage sinonasal adenoid cystic carcinoma.
-
Becotatug vedotin plus epirubicin before surgery for EGFR-positive unresectable recurrent sinonasal adenoid cystic carcinoma
This will test whether combining becotatug vedotin with epirubicin can shrink EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma enough to allow surgery or improve disease control.
-
Epirubicin chemoembolization to shrink sinonasal adenoid cystic carcinoma
This treatment tries three sessions of targeted transarterial Epirubicin chemoembolization in people with locally advanced sinonasal adenoid cystic carcinoma to shrink tumors and decide if surgery can be avoided.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.