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Adenoid Cystic CarcinomaPhase 2ACCONCT04214366

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

A Phase 2 study testing Carbon ion irradiation and Bimodal irradiation in people with Adenoid Cystic Carcinoma, run by Heidelberg University at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
Carbon ion irradiation and Bimodal irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteGermany
Study dates
1 Dec 2019to 1 Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Informed consent
  • KI > 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)
  • Age 18-80 years

Who cannot join

  • 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, ...)
Show all 9Show fewer
  • Contraindication to MR imaging
  • Simultaneous participation in another clinical study that could influence the outcome of this study or the other study
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Klaus Herfarth, Prof. Dr. contact

+49 6221 56 8201

klaus.herfarth@med.uni-heidelberg.de

Germany1 site, 1 recruiting

  • University of Heidelberg, Radiooncology, HIT

    Heidelberg, 69120

    Klaus Herfarth, Prof. Dr., +49 6221 568201, klausherfarth@med.uni-heidelberg.de

    Klaus Herfarth, Prof. Dr.

    Recruiting

Other trials in Germany

About this study

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.

Being tested
Carbon ion irradiation, Bimodal irradiation
Keywords
carbon ion, heavy ion, salivary gland tumor, ACC, Radiation therapy
Medical subject headings
Carcinoma, Adenoid Cystic, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbon ion irradiationRadiation

    22 x 3 Gy(RBE) Carbon Ions

  • Bimodal irradiationRadiation

    25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Study groups in NCT04214366
Study groupRoleWhat they receive
Carbon Ion irradiationExperimental22 x 3 Gy(RBE) Carbon Ions
Receives: Radiation: Carbon ion irradiation
Bimodal ArmActive comparator25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost
Receives: Radiation: Bimodal irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from loco-regional progression

    Freedom from loco-regional tumor progression according to MR imaging

    Measured: at 5 years

Secondary outcomes (4)

  1. Progression-free survival

    Progression-free survival

    Measured: at 3 and 5 years

  2. Overall survival

    Overall survival

    Measured: at 3 and 5 years

  3. Acute toxicities

    Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)

    Measured: during and up to 6 weeks after radiotherapy

  4. Late toxicities

    Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start1 Dec 2019
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04214366
Sponsor's protocol ID
ACCO
Acronym
ACCO
Status last verified
Nov 2023
First submitted
24 Sep 2019
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5.

    PubMed 34266402

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carbon ion irradiation and Bimodal irradiation in people with Adenoid Cystic Carcinoma, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Klaus Herfarth, Prof. Dr. (+49 6221 56 8201, klaus.herfarth@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from loco-regional progression (time frame: at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04214366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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