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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO)

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ClinicalTrials.gov Identifier: NCT04214366
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Tracking Information
First Submitted Date  ICMJE September 24, 2019
First Posted Date  ICMJE January 2, 2020
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE December 15, 2019
Estimated Primary Completion Date January 1, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
Freedom from loco-regional progression [ Time Frame: at 5 years ]
Freedom from loco-regional tumor progression according to MR imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
  • Progression-free survival [ Time Frame: at 3 and 5 years ]
    Progression-free survival
  • Overall survival [ Time Frame: at 3 and 5 years ]
    Overall survival
  • 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)
  • Late toxicities [ Time Frame: up to 5 years ]
    Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Official Title  ICMJE Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenoid Cystic Carcinoma
Intervention  ICMJE
  • Radiation: Carbon ion irradiation
    22 x 3 Gy(RBE) Carbon Ions
  • Radiation: Bimodal irradiation
    25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost
Study Arms  ICMJE
  • Experimental: Carbon Ion irradiation
    22 x 3 Gy(RBE) Carbon Ions
    Intervention: Radiation: Carbon ion irradiation
  • Active Comparator: Bimodal Arm
    25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost
    Intervention: Radiation: Bimodal irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2019)
314
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2032
Estimated Primary Completion Date January 1, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Klaus Herfarth, Prof. Dr. +49 6221 56 8201 klaus.herfarth@med.uni-heidelberg.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04214366
Other Study ID Numbers  ICMJE ACCO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Klaus Herfarth, MD, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Klaus Herfarth, Prof. Dr. University Hospital Heidelberg
PRS Account Heidelberg University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP