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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214366
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Radiation: Carbon ion irradiation Radiation: Bimodal irradiation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2027
Estimated Study Completion Date : December 1, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carbon Ion irradiation
22 x 3 Gy(RBE) Carbon Ions
 Radiation: Carbon ion irradiation
22 x 3 Gy(RBE) Carbon Ions
Active Comparator: Bimodal Arm
25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost
 Radiation: Bimodal irradiation
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from loco-regional progression [ Time Frame: at 5 years ]
    Freedom from loco-regional tumor progression according to MR imaging


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 3 and 5 years ]
    Progression-free survival

  2. Overall survival [ Time Frame: at 3 and 5 years ]
    Overall survival

  3. Acute toxicities [ Time Frame: during and up to 6 weeks after radiotherapy ]
    Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)

  4. Late toxicities [ Time Frame: up to 5 years ]
    Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214366


Contacts
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Contact: Klaus Herfarth, Prof. Dr. +49 6221 56 8201 klaus.herfarth@med.uni-heidelberg.de

Locations
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Germany
University of Heidelberg, Radiooncology, HIT Recruiting
Heidelberg, Germany, 69120
Contact: Klaus Herfarth, Prof. Dr.    +49 6221 568201    klausherfarth@med.uni-heidelberg.de   
Principal Investigator: Klaus Herfarth, Prof. Dr.         
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Klaus Herfarth, Prof. Dr. University Hospital Heidelberg
  Study Documents (Full-Text)

Documents provided by Klaus Herfarth, MD, Heidelberg University:
Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Klaus Herfarth, MD, Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology, Heidelberg University
ClinicalTrials.gov Identifier: NCT04214366    
Other Study ID Numbers: ACCO
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Herfarth, MD, Heidelberg University:
carbon ion
heavy ion
salivary gland tumor
ACC
Radiation therapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma