Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2027

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Freedom from loco-regional progression
    • Time Frame: at 5 years
    • Freedom from loco-regional tumor progression according to MR imaging

Secondary Measures

  • 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)

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heidelberg University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Klaus Herfarth, MD, Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology – Heidelberg University
  • Overall Official(s)
    • Klaus Herfarth, Prof. Dr., Principal Investigator, University Hospital Heidelberg
  • Overall Contact(s)
    • Klaus Herfarth, Prof. Dr., +49 6221 56 8201, klaus.herfarth@med.uni-heidelberg.de

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