Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Sponsor
Heidelberg University
Study ID
NCT04214366
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Carbon ion irradiation — RADIATION
    22 x 3 Gy(RBE) Carbon Ions
  • Bimodal irradiation — RADIATION
    25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Study Details

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.

Key Dates

Start date
Dec 1, 2019
Status verified
Nov 2023
Primary completion
Dec 1, 2027
Completion
Dec 1, 2032

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Freedom from loco-regional progression [ Time Frame: at 5 years ]

Central Contacts

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