Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Brief Title

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Official Title

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Freedom from loco-regional progression

Secondary Outcome

 Progression-free survival

Condition

Adenoid Cystic Carcinoma

Intervention

Carbon ion irradiation

Study Arms / Comparison Groups

 Carbon Ion irradiation

Description:  22 x 3 Gy(RBE) Carbon Ions

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Radiation

Estimated Enrollment

314

Start Date

December 15, 2019

Completion Date

January 1, 2032

Primary Completion Date

January 1, 2032

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Klaus Herfarth, Prof. Dr., +49 6221 56 8201, [email protected]

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT04214366

Organization ID

ACCO

Responsible Party

Principal Investigator

Study Sponsor

Heidelberg University

Study Sponsor

Klaus Herfarth, Prof. Dr., Principal Investigator, University Hospital Heidelberg

Verification Date

December 2019