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New treatment option for Adenoid Cystic Carcinoma
Official title Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
ClinicalTrials.gov ID: NCT04214366
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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, ...)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.