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Clinical Trial NCT04214366 (ACCO) for Adenoid Cystic Carcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO) Phase 2 314 Open-Label Combination Therapy Investigator-Initiated Overall Survival

Recruiting
Clinical Trial NCT04214366 (ACCO) is designed to study Treatment for Adenoid Cystic Carcinoma. It is a Phase 2 interventional study that is recruiting, having started on December 1, 2019, with plans to enroll 314 participants. Led by Heidelberg University, it is expected to complete by December 1, 2032. The latest data from ClinicalTrials.gov was last updated on November 30, 2023.
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 ...Show More
Official Title

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Conditions
Adenoid Cystic Carcinoma
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ACCO
NCT ID Number
NCT04214366
Start Date (Actual)
2019-12-01
Last Update Posted
2023-11-30
Completion Date (Estimated)
2032-12-01
Enrollment (Estimated)
314
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
carbon ion
heavy ion
salivary gland tumor
ACC
Radiation therapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCarbon Ion irradiation
22 x 3 Gy(RBE) Carbon Ions
Carbon ion irradiation
22 x 3 Gy(RBE) Carbon Ions
Active ComparatorBimodal Arm
25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost
Bimodal irradiation
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Freedom from loco-regional progression
Freedom from loco-regional tumor progression according to MR imaging
at 5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression-free survival
Progression-free survival
at 3 and 5 years
Overall survival
Overall survival
at 3 and 5 years
Acute toxicities
Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)
during and up to 6 weeks after radiotherapy
Late toxicities
Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)
up to 5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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
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Study Responsible Party
Klaus Herfarth, MD, Principal Investigator, Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology, Heidelberg University
Study Central Contact
Contact: Klaus Herfarth, Prof. Dr., +49 6221 56 8201, [email protected]
1 Study Locations in 1 Countries
University of Heidelberg, Radiooncology, HIT, Heidelberg, 69120, Germany
Klaus Herfarth, Prof. Dr., Contact, +49 6221 568201, [email protected]
Klaus Herfarth, Prof. Dr., Principal Investigator
Recruiting