NCT04214366 Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
| NCT ID | NCT04214366 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Heidelberg University |
| Condition | Adenoid Cystic Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 314 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 314 participants in total. It began in 2019-12-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Klaus Herfarth, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT04214366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Adenoid Cystic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04214366 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04214366 currently recruiting?
Yes, NCT04214366 is actively recruiting participants. Contact the research team at klaus.herfarth@med.uni-heidelberg.de for enrollment information.
Where is the NCT04214366 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT04214366 clinical trial?
NCT04214366 is sponsored by Heidelberg University. The principal investigator is Klaus Herfarth, Prof. Dr. at University Hospital Heidelberg. The trial plans to enroll 314 participants.