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NCT Number: NCT04214366

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

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.

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Key information

Conditions

Adenoid Cystic Carcinoma Adenocarcinoma Carcinoma Carcinoma, Adenoid Cystic Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Heidelberg, Radiooncology, HIT

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Klaus Herfarth, Prof. Dr.

CONTACT

[email protected]

+49 6221 568201

Klaus Herfarth, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Freedom from loco-regional progression

    Time frame: at 5 years

    Freedom from loco-regional tumor progression according to MR imaging

Secondary outcomes

  1. Progression-free survival

    Time frame: at 3 and 5 years

    Progression-free survival

  2. Overall survival

    Time frame: at 3 and 5 years

    Overall survival

  3. 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)

  4. Late toxicities

    Time frame: up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Klaus Herfarth, Prof. Dr.

CONTACT

[email protected]

+49 6221 56 8201

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Acronym: ACCO

Important dates

Study start
2019
Primary completion
2027
Study completion
2032
First posted
Jan 2, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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