Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study.
Kristin Lang, Sebastian Adeberg, Semi Harrabi...
https://pubmed.ncbi.nlm.nih.gov/34266402Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID04214366
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Led by Heidelberg University · Updated on 2023-11-30
314
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Adenoid cystic carcinoma is a rare type of tumor found in the head and neck region. Because these tumors grow slowly but have a high risk of spreading, additional radiation treatment is often needed. This study, called ACCO, is a phase II, open-label trial led by Heidelberg University Hospital, focused on using only carbon ion radiation for this tumor type. The goal is to see if carbon ion therapy alone can improve local tumor control rates from 60% to 70% over five years. The study compares two radiation approaches: one group receives only carbon ion irradiation in 22 sessions over about 4 weeks, while the other group receives a combination of photon intensity-modulated radiation therapy (IMRT) and a carbon ion boost. This shorter schedule of carbon ion therapy is being evaluated for its effectiveness. Patients will be followed for five years after starting treatment to assess outcomes. Participants will undergo regular assessments including monitoring for tumor progression, survival, side effects during and after treatment, and quality of life. The primary measure is freedom from tumor progression in the treated area after five years. Secondary measures include progression-free survival, overall survival at 3 and 5 years, and both acute and late treatment-related toxicities. The study aims to enroll 175 patients and will closely track their health throughout the follow-up period.
CONDITIONS
Brief Title
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Who Can Participate
Age: 18Years - 80Years
All Genders
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 pT3/pT4
- Informed consent given
- Karnofsky index > 60% or ECOG performance status 0/1 (minimum self-sufficiency, normal activity or work not possible)
- 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 (clinical or pathological)
- Previous radiotherapy in the head and neck region
- Active medical implants without ion radiation approval (e.g., pacemaker, defibrillator)
- Contraindication to MRI imaging
- Participation in another clinical study that may affect outcomes
- Pregnancy
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 5 weeks
Participants receive either carbon ion irradiation or bimodal irradiation as part of their treatment for adenoid cystic carcinoma.
Daily visits for radiation treatment sessions
Follow-up
Duration - Up to 5 years
Participants are monitored for acute toxicities during and up to 6 weeks after radiotherapy, as well as late toxicities and survival outcomes up to 5 years.
Regular follow-up visits during the first 6 weeks post-treatment and periodic visits up to 5 years
Trial Site Locations
Total: 1 location
1
University of Heidelberg, Radiooncology, HIT
Heidelberg, Germany, 69120
Actively Recruiting
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Research Team
K
Klaus Herfarth, Prof. Dr.
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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