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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

NCT04214366 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Adenoid Cystic Carcinoma

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

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Klaus Herfarth, Prof. Dr. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2027-12-01
Completion
2032-12-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214366 on ClinicalTrials.gov